ION MAGNUM GENIUS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for ION GENIUS. The logo consists of the words "ION GENIUS" in a stylized font, with a three-dimensional cube made of interconnected circles above the words. The cube is made up of smaller circles connected by lines, creating a lattice-like structure. ### JUN 2 1 2013 ### TRADITIONAL 510 K SUMMARY 1833 Kalakaua Ave, Suite 905 Honolulu, HI 96821 Phone: +1-866-25-YOUNG/808-395-0656 FAX: 877-26-YOUNG/808-395-0787 Email:info@arasysperfector.com Website www.arasysperfector.com ### 510(k) Summary K123158 lon Genius, Inc. / Ion Magnum LTD / UV Innovations Ltd Corporate Headquarters and Shipping Address 1833 Kalakaua Ave Suite #905 Honolulu, HI 96815 Manufacturing Facility UV Innovations Ltd BIC 1 Innova Park Mollison Ave, Enfield, Middlesex, EN3 7XU, UK UK: +442032861886 USA +1 808 395-0656 * +1-866-25-YOUNG +1-808 395 0787 quality@iellios.com research@iellios.com 1-808 6461948 ### Submitter's name: Address: Telephone: FAX: Company E-mail: Contact Person: Contact Person Telephone: Date of Summary {1}------------------------------------------------ ls re-submitted: FDA Establishment Registration No: Proprietary Name: Regulation Description: Panel Code Product Code: Submission Type Regulation Number Device Class Trade Name: Common Name: Classification Name: Distributed by: June, 2013 3003588228 (Ion Genius Inc) lon Magnum Genius Powered Muscle Stimulator for Muscle Conditioning ва NGX 510(k) 890.5850 ll ION MAGNUM GENIUS Powered Muscle Stimulator for Muscle Conditioning Stimulator, muscle, powered, for muscle conditioning Ion Genius, INC / Ion Magnum LTD / UV Innovations LTD Corporate Headquarters and Shipping Address: 1833 Kalakaua #905 Honolulu, HI 96815 Tel: 866-25-YOUNG tel:808-395-0656 Fax: 877-26-YOUNG PREDICATE: Legally Marketed Devices > 1. Compex Sport Compex, S.A. Regulation No 890,5850 K 011880 Stimulator, muscle, powered, for muscle conditioning Product Code: NGX | Action Taken to Comply with the | Yes. A new improvement in the device design to | |---------------------------------------|---------------------------------------------------| | requirements of section 514 | enhance the device safety was the additional | | of the act, regarding compliance | insulation of wires and other components near the | | with applicable performance standards | chassis which is connected to the ground and the | | in accordance with 121 CFR 807.87 (d) | increase of the gap between wires and all other | | | components and chassis to 9 milimeters. This new | | | design significantly reduces the risk that the | {2}------------------------------------------------ | | connections could be shorted to the ground.<br>Manufacturing facility has been awarded ISO 13485:<br>2003 for the manufacture and sales of muscle<br>stimulators 2011-2014. There are extensive<br>Bench tests prior to each Ion Magnum being<br>released by the manufacturing facility with the pass<br>sticker and the date that it passed next to the serial<br>number of the device | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### Device Description: lon Magnum Genius is a muscle stimulator with six ports and one output that is the same for all ports. The unit is designed for healthy men & women to provide muscle conditioning. Ion Magnum Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz which are within the same range as the predicate that offer a range from 1-120 Hz. The setting that the frequency button is turned shows which frequency the device is set on. The device delivers a voltage of 50 volts at 500 Ohms load and 100ma just like the predicate. It delivers a voltage of 200 volts at 10K Ohms just like the predicate. The lon Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The lon Macnum has a maximum output current of 200 volts which is equivalent to the maximum output current of the predicate. The device primarily treats abdominal muscles (ABS). LCD shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current requlated technology. The unit is easy and simple to use. Ion Magnum is suitable for use by all healthy adults. However as with other muscle stimulators some care is needed when using the lon Magnum Genius [see contraindications and warnings in manual] NOTE 1: All channels outputs are isolated from each other. They have their own transformers and amplifiers which are independent from neighboring channels or outputs. The only common thing between the outputs is their connectors to the power supply, the start button, the programs button and the pulse button. There is a transformer that translates energy received from the mains into micro currents. Hence there is an insulation of mains from circuitry. From Circuitry to output there is also insulation through the transformer. Therefore there is a double separation between mains and the human body. 3 This unit contains 24 self-adhesive electrodes that already have 510K clearance (K970426) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a device labeled "ION MAGNUM GENIUS". The device has several knobs and buttons on its side. The top of the device has a pattern of dots. The lon Magnum power source is 110V - 240 V AC Mains, 50-60Hz The patient leakage current is 0.07 microamps under both the normal and fault conditions.. A new improvement in the device design was made in 2012 in order enhance the device safety which entailed the additional insulation of wres and other components near the chassis. The increase of the gap between wires and all other components and chassis is now increased at least 9 millimeters. This new design safety significantly reduces the risk that the connections could be shorted to the ground. Channels are synchronous and are isolated by separate transformers the way the channels or the predicate are synchronous and isolated by separate transformers. Ion Magnum Genius has an automatic overload trip, just like the predicate but not an automatic no load trip just like the predicate that do not have a no load trip, therefore in terms of the overload trip features the lon Magnum Genius and the predicate are substantially equivalent. The lon Magnum Genius is also equivalent to the predicate in that it has an automatic shut off and patient override control for additional safety. Indicator displays include on and off status just like it does in the predicate. Ion Magnum Genius is an IEC 1 device, IEC 60417-5333, type BF applied part device. | Question | Yes | No | |---------------------------------------------------------------------------------------|-----|----| | Is the device intended for prescription use (21 CFR 801 Subpart D)? | X | | | Is the device intended for over-the-counter use (21 CFR 807 Subpart | | X | | Does the device contain components derived from a tissue or<br>other biologic source? | | X | | Is the device provided sterile? | | X | | Is the device intended for single use? | | X | | Is the device a reprocessed single use device? | | X | | If yes, does this device type require reprocessed validation data? | | | #### Design and Use of the Device {4}------------------------------------------------ | Does the device contain a drug? | | X | |---------------------------------------------------|---|---| | Does the device contain a biologic? | | X | | Does the device use software? | | X | | Does the submission include clinical information? | X | | | Is the device implanted? | | X | ### Intended Use lon Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The lon Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the lon Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The lon Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. {5}------------------------------------------------ ### COMPARISON OF INDICATIONS FOR USE OF ION MAGNUM GENIUS AND PREDICATE | Ion Magnum Genius is intended for muscle | Compex Sport" (K01180) is intended for | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | conditioning to stimulate healthy muscles. The Ion | muscle conditioning to stimulate healthy | | Magnum Genius is not intended to be used in | muscles in order to improve or facilitate muscle | | conjunction with therapy or treatment of medical | performance. | | diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. | "Compex® Sport" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "Compex® Sport" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. | Substantial Equivalence based on the Indicatins of Use Statement: When compared to the predicated device, Compex® Sport K011880 the lon Magnum Genius has the same intended use. Therefore, the lon Magnum Genius is substantially equivalent to the predicate marketed device Compex® Sport KO11880. б {6}------------------------------------------------ ### COMPARISON OF DEVICE DESCRIPTION, SAFETY AND EFFECTIVENESS OF ION MAGNUM GENIUS TO PREDICATE DEVICES: | Ion Magnum Genius is a Muscle stimulator with<br>six independent channels which electrical<br>current can be regulated individually<br>Biphasic rectangular impulses with electrical mean<br>equal to zero. Maximum output current is 100 mA<br>and maximum voltage output is 200 volts. The<br>device gives 50V output at 500 Ohms overload and<br>200 volts at 10K Ohms overload. Maximum<br>quantity of electricity per channel:40 µC Impulse<br>width: 400 to 500 µsecs. The three Ion Magnum<br>Genius frequencies, 90 Hz, 100 and 120Hz are<br>within the same range as the predicate. The<br>electrical pulses generated by the Ion Magnum Genius<br>are transmitted to the muscles via self-adhesive<br>electrodes, Axelgaard type electrodes electrodes (<br>510K K970426) The electrodes are equivalent to<br>those used by the predicate. | Compex Sport" (K01180) has:<br>Four independent channels which electrical current can<br>be regulated individually. Biphasic rectangular impulses<br>with electrical mean equal to zero<br>Maximum output current is 100 mA and maximum<br>voltage output is 200 volts. The device gives 50V output<br>at 500 Ohms overload and 200 volts at 10K Ohms<br>overload. Maximum quantity of electricity per channel: 40<br>µC impulse width: 200 or 400 µS. Range of pulse<br>frequency: 1-120 Hz The electrical pulses generated by<br>'Compex® Sport" are transmitted to the muscles via self-<br>adhesive electrodes. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### Other equivalence aspects between lon Magnum Genius and the Predicate | Other<br>equivalence<br>aspects<br>between Ion<br>Magnum<br>Genius and<br>the Predicate | 1. Ion Magnum Genius and the predicate devices are identical in terms of the<br>thermal safety (there is no thermal energy for Ion Magnum Genius or the<br>predicate) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. The chemical safety is equivalent (since this is applicable to neither the Ion<br>Magnum Genius nor the predicate) | | | 3. Sterility is equivalent (since neither the Ion Magnum Genius nor the predicate<br>require sterilization or are supplied sterile.) | | | 4. The Ion Magnum Genius uses disposable pads that do not need sterilization that<br>are equivalent to the pads of the predicate which also do not need sterilization<br>because they are disposable. | | | 5. Biocompatibility of the Ion Magnum disposable pads is equivalent to those of the<br>predicate. Biocompatibility is performed by the company from which these<br>disposable pads are purchased (Axelgaard). Ion Magnum uses disposable pads<br>item no: SN2020 which are square 2" x 2" (5cm x 5cm) which have a 510K<br>number K970426 and comply to ISO10993-5 Biological Evaluation of Medical<br>Devices part 5 Test for in vitro cytotoxicity & ISO10993-10. The are made by<br>Axelgaard Manufacturing Co. LtD, 520 Industrial Way Fallbrook California 92028,<br>USA which has a Certificate of Registration Quality Management System - ISO<br>13485:2003 and holds certificate no FM 40363 and operates a Quality<br>Management System which complies with the requirements of ISO 13485: 2003<br>for the following scope: The design and development, manufacture and | | {7}------------------------------------------------ | distribution of hydrogel and non-invasive electrodes: Effective date 03/11/2012<br>- Expiry Date: 03/12/2015.] | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 6. The cables carrying the impulses to the pads and the connectors are both<br>designed to insulate the client and operator from inadvertent contact with the<br>relatively weak electrical impulses. Should the connectors be dislodged in use, for<br>instance, by the client changing position during treatment, the insulation will<br>ensure no direct contact with the skin will take place. The lon Magnum cables<br>remain screwed on and attached to the device as are the cables of the predicate<br>devices. | · #### output specifications comparing ion Magnum Genius With THE PREDICATE DEVICES . ・ | | ION MAGNUM<br>GENIUS | Compex Sport<br>K011880 | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | Waveform | Biphasic<br>synchronous | Biphasic<br>synchronous | | Synchronous or<br>alternating channels | synchronous | synchronous | | Dimension of Device | 15.5 inches length<br>8.5 height<br>7.5 width | Length: 142 mm<br>Width 99mm<br>Height 36mm | | Weight of the<br>Device | 8 pounds | 350 g | | Weight of<br>Accessories | 4.7 pounds | 95 g | | Indicator Display | Yes | Yes | | Low Battery | N/A | Yes | | Voltage Current<br>Level | Yes | Yes | | Shape | Rectangular | Rectangular | | Max Output Voltage | 50V @ 500 Ω | 50V | | Net Charge | 200 V @10k Ω<br>0.01 amperes at<br>500 Ohms<br><br>0.004 Amperes at<br>2K ohms<br><br>0.0025 Amperes at<br>10K Ohms | 200 V +/-10 | | Max Output Current | 100 ma at 500<br>Ohms | 100 ma at 500 Ohms | | Frequency (Hz)<br>for Muscle<br>Conditioning | 90 Hz<br>100 Hz<br>120Hz | 1-120 Hz | | Pulse Duration | 416 - 500 µsec | 200 to 400 µsec | | Pulse Width | 416 - 500 µsec | 200 to 400 µsec | | Maximum Phase<br>Charge | 50 µC @ 500 Ω at<br>90 and 100 Hz<br><br>40 µC @ 500 Ω at<br>120 Hz | 40 µC | | Maximum Current<br>Density (mA/cm2) | 4 mA / cm2 | 4 mA/cm2 | | Maximum Power<br>Density (W/Cm2) | 0.0012 W/cm^2 | 0.038 W/cm^2. | | Current or Voltage<br>Driven | Current Driven<br>Voltage | Current Driven<br>Voltage | | Symmetrical<br>Phases of Waveform | Yes | Yes | | Regulated<br>Current/ voltage | Regulated Voltage<br>and Regulated<br>Current. | Constant Current Regulator /<br>regulated current | | Method of Channel<br>Isolation | Channels are<br>isolated by<br>separated<br>transformers | Channels are isolated by separated<br>transformers | | Self Adhesive<br>Electrodes Axelgaard<br>Tyoe | identical | Identical | | Current Leakage | $0.07 \mu A$ | $>100$ microamps | {8}------------------------------------------------ and the comments of the comments of the comments of the comments of : {9}------------------------------------------------ ### DIFFERENCES BETWEEN ION MAGNUM AND PREDICATE.. - 1. The lon Magnum Genius has 6 channels while the Compex Sport has 4 channels. However. the exact same output comes out of all lon Genius channels. Risk assessment testing has indicated that output coming out of six channels simultaneously is equally safe as output coming out of four channels simultaneously. - 2. The lon Magnum Genius does not have software, a microcomputer or firmware, while the predicate device is controlled by a microcomputer. However this difference does neither affect the indications of use or the safety and effectiveness of the lon Magnum Genius. - 3. THE ION MAGNUM GENIUS IS ONLY OFFERED UNDER PERSCRIPTION AND IT IS ONLY OFFERED AS A BUSINESS TO BUSINESS DEVICE SOLD ONLY TO PHYSICIANS WHICH MEANS THAT THE ION MAGNUM GENIUS WILL BE NEVER BE USED BY AN INDIVIDUAL AT HOME. ADMINISTRATION OF THE ION MAGNUM TREATMENT WILL ALWAYS BE BY A TRAINED PHYSICIAN AND THEREFORE A PATIENT RECEVING A TREATMENT WITH THE ION MAGNUM TREATMENT WILL ALWAYS HAVE THE ADVANTAGE OF THE PHYSICIAN'S CLINICAL JUDGEMENT. A PHYCISIAN WILL ALSO BE AVAILABLE FOR CONSULTATION WITH ANYTHING REGARDING THE ION MAGNUM AND OVERALL ADDITIONAL SAFETY. - 4. The lon Magnum Genius has a different weight than the predicate. However this difference does neither affect the indications of use or the safety and effectiveness of the lon Magnum Genius. ### SUBSTANTIAL EQUIVALENCE DISCUSSION #### 1. Substantial Equivalence on the basis of Indication for Use The lon Maqnum and the predicate devices have the same intended use and equivalent indications. and principles of operation that includes the delivery of small amount of electrical stimulation to healthy skeletal muscles for conditioning of the muscles. ### 2. Substantial Equivalence on the basis of Technological characteristics: The lon Magnum Genius and the predicate have a number of similarities in terms of their technological characteristics cited below: - 1 . Biphasic Rectangular Waveform - 2. Synchronous channels - 3. Maximul output voltage - 4. Maximum output current - 5. range of frequencies - 6. Pulse Duration - 7. Pulse width - 8. Maximum Phase Charge - 9. Maximum Current Density {10}------------------------------------------------ 10. Channels' method of isolation by separate transformers . . . . : . . . : : 1 1 . Identical Electrodes : 12. Similar current leakage {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like bird with three curved lines representing its wings and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. Public Health Service June 21, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 lon Genius c/o Xanya Sofra-Weiss, Ph.D. Director of Research and Training 7192 Kalanianole Hwy #D-204A Honolulu. HI 96821 Re: K123158 Trade/Device Name: Ion Magnum Genius Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June, 2013 Received: June 7, 2013 Dear Dr. Sofra-Weiss: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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 of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. 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). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {12}------------------------------------------------ Page 2 - Xanya Sofra-Weiss, Ph.D. CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetw/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. # Joyce M. Whang -S for Victor Krauthamer. Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K123158 Device Name: Ion Magnum Genius Indications For Use: lon Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The lon Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the lon Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The lon Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | .<br> | . | 1<br>1<br> | |------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (Divicion Sinn I | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Division of Neurological and Physical Medicine Devices (DNPMD) 510(k) Number _ K123158 __ Page 1 of 1