O n APR 2 8 2914

TRADITIONAL 510 K SUMMARY

K1 32179

1833 Kalakaua Ave, Suite 905 Honolulu, HI 96821Phone: + 1-866-25-YCUNG/808-395-0656 FAX: 877-26-YCUNG/808-395-0787

Email:info@arasysperfector.com Webosite www.arasysperfector.com

51 C[k] Summary

Submitter's name: Ion Genius, Inc.

Corporate Headquarters

Address: 1833 Kalakaua Ave

Suite #905

Honolulu, HI 96815

Manufacturing Facility

UV Innovations Ltd

SIC 1 Innova Park

Mollison Ave, Enfield,

Middlesex, EN3 7XLJ, UK

Telephone: UK: +442032861886

USA +1 808 395-0656 * ±1-866-25-YOUNGFAX: +1-808 395 0787

22

Company E-mail: gualitViellios.com

Contact Person: researchielios.com

Contact Person Telephone: 1- 808 8461948

Date of Summary

Is re-submitted: February, 2014

FDA Establishment Registration No: 3003588228 (Ion Genius Inc]

Proprietary Name: Arasys Genius

Common Name: Muscle Stimulator for Conditioning

Regulation Description: Powered Muscle Stimulator for Muscle Conditioning

Panel Code 89

Product Code: N OX

Submission Type 51 0[k)

Regulation Number 890.5850

Device Class 11

Trade Name: ARASYS GENIUS

Common Name: Powered Muscle Stimulator for Muscle Conditioning

Classification Name: Stimulator, muscle, powered, for muscle conditioning

Contact Person: Xanya Sofra Weiss. Ph.D

Contact Person e-mail research@iellios.com

Contact Person Telephone: 1- 808 6461948

Date that the Summary wasprepared July, 2013

Distributed by: Ion Genius, INCCorporate Headquarters18e33 Kalakaua #905Honolulu, HI 98815Tel: 866-25-YOUNG tel:808-395-0656Fax: 877-26-YOUNG

23

PREDICATE:

1.. Ion Magnum GeniusContact Name: Xanya Sofra-Weiss. Ph.DIon Genius Inc / Ion Magnum LTDRegulation No 890.5850K 123158Stimulator, muscle, powered, for muscle conditioningProduct Code: NGX

Device Description: The Arasys Genius has the exact same technological characteristics, the samenumber of channels and the exact same frequencies as the predicate,. Arasys Genius is made by UVInnovations by the same engineers and technicians that make the Ion Magnum Genius K1 231 58. ArasysGenius has the exact same technology of the predicate, Ion Magnum Genius K1 23158 with theexceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one outputthat is the same for all ports just like the predicate. The unit is designed for healthy men & women toprovide muscle conditioning. Arasys Genius stimulator provides selections of different programs throughmanual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, and 120 Hz. in anidentical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which isequivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows thebalance treatment time in the same fashion as it happens with the predicate. The output signal isbiphasic, rectangular and based on a voltage and current regulated technology as it does in thepredicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like thepredicate as it is intended for muscle conditioning to stimulate healthy muscles. The Ar-asys Genius is notintended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of anykind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on suchmuscles is contra indicated. The Arasys Genius is only offered under prescription given by a physicianlicensed in the state in which he or she practices.

NOTE 1: All channel-s outputs are isolated from each other. They have their own transformers andamplifiers which are Independent from neighboring channels or outputs. The only common thingbetween the outputs is their connectors to the power supply the start button, the programs buttonand the pulse button.There is a transformer that translates energy received from the mains into micro currents. Hencethere is an insulation of mains from circuitry. From Circuitry to output there is also insulation throughthe transformer. Therefore there is a double separation between mains and the human body,

This unit contains 32 self-adhesive electrodes that already have 510OK clearance (K970426)

The Arasys Genius power source is 11 CV - 240 V AC Mains, 50-60 Hz which are identical to thepredicate. The patient leakage current is 0.07 microamps under both the normal and fault conditionswhich are again are the exact same specs as the predicate. Channels are synchronous and are isolated byseparate transformers the way the channels of the predicate are synchronous and isolated by separate

24

transformers. Arasys Genius has an automaticoverload trip, lust like the predicate but not anautomatic no load trip lust like the predicate that doesnot have a no load trip, therefore in terms of theoverload trip features the Arasys Genius and thepredicate are identical.. The Arasys Genius is alsoequivalent to the predicate in that it has an automaticshut off and patient override control for additionalsafety. Indicator displays include on and off status lustlike it does in the predicate. Arasys Genius is an 1ECClass 1 device and an IEC 6041 7-5333, type BEapplied part device exactly like the predicate.

Proposed Conditions for Use: Both the Arasys Genius and the predicate, the Ion Magnum GeniusK1 23156 are meant to be used in a professional setting like a spa, a medical spa or a professional officeand to be operated by a professional and not by the patient.

In terms of how the device interacts with other devices. Neither the Arasys Genius nor the predicate theIon Magnum Genius K1 23158 affect or are affected by other devices that may be in the same spa oroffice room.

In terms of how the Device interacts with the patient: Both Arasys Genius and Ion Magnum GeniusK1 23158 interact in the same way with the patient. Both devices have cables that are screwed into thedevice. The other end of each cable has clips covered in plastic that snap into self adhesive pads. The selfadhesive pads used both with the Arasys Genius and the predicate have been cleared (K970426] andtherefore, they have been independently tested for biocompatibility, electrical performance, adhesiveperformance, stability, and reuse of such electrodes. These cleared self adhesive pads and they areapplied onto the patient's muscles in the same fashion in both the Arasys Genius and the predicate.

The expected life of the device at least 10 to 15 years because inside the machine are microswitchesthat last far about 50,000 hours. Our company Ion Genius Inc offers life warranty on the Ion MagnumGenius. This means that we will repair any parts for free for as long as the customer owns the device.

The device enclosure has no protection against water because if the machine is completely closed up itmay become overheated which will damage the device. There is a warning to keep the device away from

liquids and water both on the device and the manual.The Device is for non-continuous operation.The Arasys Genius is identical to the Ion MagnumGenius in that it has 6 3-pin din sockets that arelocated three on each side of the device THE DEVICECABLES SCREW INTO THE DEVICE AND REMAINSCREWED AT ALL TIMES. As seen in the picturesthere are no exposed parts in the plastic covered

_ cables so whoever is holding the cable is completelyinsulated and safe. ALL parts are touchproof Thesilver part that you see at the 3-pin din ending thatgoes into the device is plastic, so whoever holds it iscompletely insulated and safe. There are no exposedparts. Overall, the ARASYS GENIUS lust like the Ion

Magnum Genius lead wires screw into the device and remain screwed in at all times comply with IEC25

60601-1-:2005 Section 8.5.2.3 where connectors for electrical connections on a patient leads shall beconstructed so that the said part cannot become connected to earth or possible hazardous voltage whilethe patient connection~s] contact the patient.

When the device is turned on, the pulses from the device are delivered to the patient's body to stimulate

and condition the muscles. This procedure is identical in both the Arasys Genius and the predicate.

The Arasys Genius technological characteristics are identical to the predicate

1. Biphasic Rectangular Waveform2. Synchronous channels3. Maximum output voltage4. Maximum output current5. Identical frequencies6. Pulse Duration7. Pulse width8. Maximum Phase Charge9. Maximum Current Density10. Channels' method of isolation by separate transformfers11. Identical Electrodes12. Similar current leakage'13. Same accessories14. Same electrodes that are cleared K97042615. Identical number of channels18. Equivalent dimensions, weight and Housing materials and construction17. Identical method of line current isolation18B. Identical net charge

Design and Use of the Device

Question Yes NoIs the device intended for prescription use (21 CFR 801 Subpart 0)? XIs the device intended for over-the-counter use (21 CFR 807 Subpart XDoes the device contain components derived from a tissue or Xother biologic source?Is the device provided sterile? XIs the device intended for single use? XIs the device a reprocessed single use device? XIf yes, does this device type require reprocessed validation data?Does the device contain a drug? XDoes the device contain a biologic? XDoes the device use software? XDoes the submission include clinical information? XIs the device implanted? ___ X

Intended Use

Arasys Genius K 132179 is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius

26

is- not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditionsof any kind None of the Arasys Genius programs is designed for injured or ailing muscles and its use on suchmuscles is contraindicated. The Arasys Genius is only offered uinder prescription given by a physician licensedin the state ih which he or she practices. The Arasys Genius is in tended to be operated by a trainedprofessional who is always present to monitor treatment.

COMPARISON OF INDICATIONS FOR USE OF ARASYSGENIUS AND PREDICATE K1 23158

Arasys Genius K 132179 is intendedfor muscle Ion Magnum Geniut K123 158 s isconditioning to stimulate healthy muscles. The intended for muscle conditioning toArasys Genius is not intended to be used in stimulate healthy muscles. ThelIonconjunction with therapy or treatment of medical Magnum Genius is not intended to bediseases or medical conditions of any kind. None of used in conjunction with therapy orthe Arasys Genius programs is designed for injured treatment of medical diseases oror ailing muscles and its use on such muscles is medical conditions of any kind. Nonecontraindicated, The Arasys Genius is only offe red of the Ion Magnum Genius programsunder prescription given by a physician licensed in is designed for injured or ailingthe state in which he or she practices. The Arasys muscles and its use on such musclesGenius is intended to be operated by a trained is contraindicated. The Ion Magnumprofessional who is always present to monitor Genius is only offered undertreatment. The A rasys Genius is intended to be prescription given by a physicianoperated by a trained profe ssional who is always licensed in the state in which he orpresent to monitor treatment. she practices.

Substantial Equivalence based an the Indicatins of Use Statement: When compared to the predicated device,Ion Magnum Genius 123158 K123 158 the Arasys Genius has the same intended use. Therefore, the ArasysGenius is substantially equivalent to the predicate marketed device Ion Magnum Genius K1 23158

27

COMPARISON OF DEVICE DESCRIPTION, SAFETY AND EFFECTIVENESS OF ARASYS GENIUS TO PREDICATEDEVICES:

Arasys GeniusKl32179 is a Muscle stimulator Ion Magnum Genius K1 23158" (KI1 2 31 5 8) iswith six independent channels which electrical a Muscle stimulator with six independent channelscurrent can be regulated individually .which electrical current can be regulated individuallyBiphasic rectangular impulses with electrical mean -Biphasic rectangular impulses with electrical mean equal toequal to zero. Maximum output current is 100 mA Z zero. Maximumr output current is 100 mA and maximumand maximum voltage output is 200 volts. The voltage output is 200 volts. The device gives 50V outputdevice gives 50V output at 500 Ohms overload and at 500 Ohms overload and 200 volts at 10OK Ohms200 volts at 10OK Ohms overload. Maximum overload. Maximum quantity of electricity per channel: 40quantity of electricity per channel:40 pC Impulse pC Impulse width: 400 to 500 psecs. The three Arasyswidth: 400 to 500 psecs. The three Arasys Genius Genius frequencies, 90 Hz. 100 and 1 20Hz are within thefrequencies, 90 Hz, 100 and 1 20Hz are within the same range as the predicate. The electrical pulsessame range as the predicate. The electrical pulses generated by theANdssiare transmitted to thegenerated by ffie~as s~nisare transmitted to the muscles via self-adhesive electrodes, Axelgaard typemuscles via self-adhesive electrodes, Axelgaard electrodes electrodes [K970426)type electrodes electrodes which are cleared [ 510OKK9.70426] The electrodes are identical to thoseused by the predicate.

Other equivalence aspects between Arasys Genius and the Predicate

Other 1 . Arasys Genius and the predicate devices are identical in terms of the thermalequivalence safety [there is no thermal energy for Arasys Genius or the predicate]aspectsbetween 2. The chemical safety is equivalent [since this is applicable to neither the ArasysArasys Genius Genius nor the predicate]and thePredicate 3. Sterility is equivalent [since neither the Arasys Genius nor the predicate require

sterilization or are supplied sterile.]

4. The Arasys Genius uses disposable pads that do not need sterilization that areequivalent to the pads of the predicate which also do not need sterilizationbecause they are disposable.

5. Biocompatibility of the Arasys disposable pads is equivalent to those of thepredicate and it is independently tested because the disposable pads are testedby the company that provides them and they are cleared (K970426).Biocompatibility is performed by the company from which these disposable padsare purchased [Axelgaard]. Arasys uses disposable pads item no: SN2020 whichare square 2' x 2" [5cm x 5cm] which have a 510OK number K970426 andcomply to 1S01 0993-5 Biological Evaluation of Medical Devices part 5 Test for invitro cytotoxicity & IS01 0993-1 0. The are made by Axelgaard Manufacturing Co.LtD, 520 Industrial Way Fallbr'ook California 92028, USA which has a Certificateof Registration Quality Management System - ISO 13485:2003 and holdscertificate no FM 40363 and operates a Quality Management System whichcomplies with the requirements of ISO 13485: 2003 for the following scope: Thedesign and development, manufacture and distribution of hydrogel and non-invasive electrodes: Effective date 03/11/2012 - Expir-y Date:

__________03/12/2015...

28

6. The cables carrying the impulses to the pads and the connectors are bothdesigned to insulate the client and operator from inadvertent contact with therelatively weak electrical impulses. Should the connectors be dislodged in use, forinstance, by the client changing position during treatment, the insulation willensure no direct contact with the skin will take place. The Arasys cables remainscrewed on and attached to the device as are the cables of the predicate devices.

7. Proposed Conditions for Use: Both the Arasys Genius and the predicate, the IonMagnum Genius K1 23158 are meant to be used in a professional setting like aspa, a medical spa or a professional office and to be operated by a professionaland not by the patient.

OUTPUT SPECIFICATIONS COMPARING ARASYS GENIUS WITHTHE PREDICATE DEVICES

ARASYS GENIUS Ion Magnum Genius EquivalentK1 32179 K123158

Waveform _ Biphasic Biphasic EquivalentSynchronous or synchronous synchronous Equivalentalternating channelsDimension of Device 15.5 inches length 15.5 inches length Equivalent

4,5 height 8,5 height-7.5 width 7.5 width :

Weight of the 8 pounds 8 pounds EquivalentDevice

Weight of 4.7 pounds 4.7 pounds EquivalentAccessoriesIndicator Display Yes Yes

EquivalentLow Battery N/A N /A

Voltage CurrentLevel Yes YesShape Rectangular Rectangular EquivalentMax Output Voltage 50V @ 500 L2 50V @ 500 n2 Equivalent

200V@l0k£2 200 V @1 kQf EquivalentMax Output Current 100 ma at 500 100 ma at 500 Ohms Equivalent

Ohms

Frequency [Hz] 90 Hz 90Hz Equivalentfor Muscle 100 Hz 100 HzConditioning 120Hz -120Hz

29

Pulse Duration 416 - 500 jisec 416 - 500 psec Equivalent

Pulse Width 416 - 500 ptsec 416 - 500 psec Equivalent

Maximum Phase 50 PiC @ 500 flat 50 pG @ 500!Q at 90 and EquivalentCharge 90 and 100 Hz 100 Hz

40OpC @SOOQ at 40 p.A500 Q at 120 Hz120 Hz

Maximum Current 4 mA/cm2 4 mA/cm2 EquivalentDensity [mA/cm2]

Maximum Power 0.0012 W/CMA 2! 0.0012 W/CMA2; EquivalentDensity [W/Cm2]

Current or Voltage Voltage Driven Current Driven EquivalentDriven VoltageSymmetrical EquivalentPhases of Waveform Yes Yes

Regulated Regulated Voltage Regulated Voltage EquivalentCurrent/ voltage

Number of Channels 6 6 Equivalent

Method of Channel Channels are Channels are isolated by EquivalentIsolation isolated by separated transformers

separatedtransformers

Self Adhesive identical Identical. EquivalentElectrodes AxelgaardTyoe K970426

30

Cables that screw into identical identical.. Equivalentthe device

Current Leakage 0.07 pA 0.07 pA Equivalent

Net Charge 10,000 10,000 microcoulombs at Equivalentmicrocoulombs at 500 Ohms500 Ohms 4,000 microcoulombs at 2K4,000 Ohmsmicrocoulombs at 2,500 microcoulombe at-2K Ohms . lOKOhms2,500microcoulombs at

____________10K OhmsMethod of Line Current Separate Separate Transformers EquivalentIsolation Transformers.

Housing Material and Metal Enclosure Metal Enclosure EquivalentConstruction

31

4'DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

*4 Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - W066-0609Silver Spring, MD 20993-002

April 28, 2014

Ion Genius, Inc.Xanya Sofra-Weiss, Ph.D.Director of Research and Training1833 Kalakaua Aye, Suite #905Honolulu, HI 96821

Re: K132179Trade/Device Name: Arasys GeniusRegulation Number: 21 CFR 890.5850Regulation Name: Powered Muscle StimulatorRegulatory Class: Class 11Product Code: NOXDated: March 17, 2014Received: March 27, 2014

Dear Dr. Xanya Sofra-Weiss:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRI1 does not evaluate information related to contract liabilitywarranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You must

Page 2 - Dr. Xanya Sofra-Weiss

comply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CER 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041or (3 01) 796-7100 or at its Internet addresshtt://www.fda.gov/MedicalDevices/ResourcesforYou/lndustry/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttv)://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7 100 or at its Internet addresshttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Carlos L. Peii.7-S

Carlos L. Pefia, PhD, MSDirectorDivision of Neurological and

Physical Medicine DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

510(k) Number (if known)K132 179

Device NameArasys Genius

Indications for Use (Describe)Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used inconjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Arasys Genius programs isdesigned for injured or ailing muscles and its use on such muscles is contraindicated. The Amasys Genius is only offered underprescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by atrained professional who is always present to monitor treatment.

Type of Use (Select one or both, as applicable)

(9 Prescription Use (Part 21 CFR 801 Subpart D) EI dyer-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. P~na -S

FORM FDA 3881 (1114) Page I of 2nckgo3 E

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fde.hhs.gov

'An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number'

FORM FDA 3881 (1/14) Page 2 of 2