Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion 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 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.

Device Description

Ion 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 Ion Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Ion Magnum 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 regulated 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 Ion Magnum Genius [see contraindications and warnings in manual]

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ion Magnum Genius" muscle stimulator, asserting substantial equivalence to a predicate device, the "Compex Sport" (K01180). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy from scratch. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would. Instead, it focuses on demonstrating equivalence to a known device.

However, I can extract the relevant information from the document that functions as acceptance criteria for demonstrating that the device is "substantially equivalent" and the "reported device performance" to meet those criteria.

Here's a breakdown of the information requested, based on the provided document:

Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)

Since this is a 510(k) submission, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the Ion Magnum Genius compares to these characteristics to establish substantial equivalence.

1. Table of acceptance criteria and the reported device performance:

Feature/Criterion (Based on Predicate Device: Compex Sport K01180)	Ion Magnum Genius Performance/Characteristic
Indications for Use: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles.	Identical: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles. Prescription use only, administered by a trained physician.
Waveform: Biphasic synchronous	Biphasic synchronous
Synchronous or alternating channels: Synchronous	Synchronous
Max Output Voltage: 50V @ 500 Ω, 200V @ 10k Ω	50V @ 500 Ω, 200V @ 10k Ω
Max Output Current: 100 mA at 500 Ohms	100 mA at 500 Ohms
Frequency (Hz) for Muscle Conditioning: 1-120 Hz	90 Hz, 100 Hz, 120 Hz (within range)
Pulse Duration: 200 to 400 µsec	416 - 500 µsec
Pulse Width: 200 to 400 µsec	416 - 500 µsec
Maximum Phase Charge: 40 µC	50 µC @ 500 Ω (90/100 Hz); 40 µC @ 500 Ω (120 Hz)
Maximum Current Density: 4 mA/cm2	4 mA/cm2
Maximum Power Density: 0.038 W/cm^2	0.0012 W/cm^2
Current or Voltage Driven: Current Driven / Voltage	Current Driven / Voltage
Symmetrical Phases of Waveform: Yes	Yes
Regulated Current/Voltage: Constant Current Regulator / Regulated Current	Regulated Voltage and Regulated Current
Method of Channel Isolation: Channels isolated by separated transformers	Channels isolated by separated transformers
Self-Adhesive Electrodes: Identical	Identical (Axelgaard type, K970426)
Current Leakage: >100 microamps (implied predicate limit)	0.07 µA (demonstrates improved safety here)
Software/Microcomputer Control: Yes	No (different, but argued not to affect safety/effectiveness)
Number of Channels: 4	6 (different, but argued equally safe via risk assessment)
Safety Features: Automatic overload trip, automatic shut-off, patient override control, wire insulation/gap design.	Automatic overload trip, automatic shut-off, patient override control, increased wire insulation/gap (9mm).
ISO Certification for Manufacturing: Not explicitly stated for predicate in comparison table.	ISO 13485:2003 for muscle stimulators (2011-2014)
Bench Tests prior to release: Not explicitly stated for predicate.	Extensive bench tests prior to each unit release.

Missing Information (Not provided in the document for this type of submission):

The following information is typically associated with clinical trials or specific performance studies, which are generally not required for a 510(k) submission when substantial equivalence is established through comparison to a predicate device. The document does not describe such studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no clinical test set is described. The comparison is primarily based on technical specifications and claims of physical characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of clinical studies, is not established for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this device is a muscle stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this device is a physical muscle stimulator and does not involve "algorithm only" performance separate from its physical application. The entire device performance is akin to "standalone" in that it performs its function. Some technical bench tests are mentioned (e.g., current leakage, electrical outputs) but these are for device specification verification, not a clinical efficacy trial.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the clinical sense. The "ground truth" here is the technical specifications and established safety/efficacy profile of the predicate device. The Ion Magnum Genius demonstrates "truth" by having equivalent (or improved, i.e., current leakage, safety design changes) technical specifications.

8. The sample size for the training set

Not applicable, as no machine learning/AI training set is described.

9. How the ground truth for the training set was established

Not applicable.

Summary of "Proof" in a 510(k) Context:

The "study that proves the device meets the acceptance criteria" in this 510(k) submission is the comprehensive comparison table and discussion of technological characteristics and intended use against the predicate legally marketed device. The manufacturer (Ion Genius, Inc.) asserts and demonstrates through specification comparison, and in some cases, risk assessment (e.g., for 6 channels vs. 4), that the Ion Magnum Genius is substantially equivalent to the Compex Sport, which is legally marketed and presumed safe and effective for its intended use. The FDA's issuance of the 510(k) clearance (K123158) confirms this finding of substantial equivalence based on the provided information.

Summary

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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

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

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.Manufacturing facility has been awarded ISO 13485:2003 for the manufacture and sales of musclestimulators 2011-2014. There are extensiveBench tests prior to each Ion Magnum beingreleased by the manufacturing facility with the passsticker and the date that it passed next to the serialnumber 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.

This unit contains 24 self-adhesive electrodes that already have 510K clearance (K970426)

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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 orother 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

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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.

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COMPARISON OF DEVICE DESCRIPTION, SAFETY AND EFFECTIVENESS OF ION MAGNUM GENIUS TO PREDICATE DEVICES:

Ion Magnum Genius is a Muscle stimulator withsix independent channels which electricalcurrent can be regulated individuallyBiphasic rectangular impulses with electrical meanequal to zero. Maximum output current is 100 mAand maximum voltage output is 200 volts. Thedevice gives 50V output at 500 Ohms overload and200 volts at 10K Ohms overload. Maximumquantity of electricity per channel:40 µC Impulsewidth: 400 to 500 µsecs. The three Ion MagnumGenius frequencies, 90 Hz, 100 and 120Hz arewithin the same range as the predicate. Theelectrical pulses generated by the Ion Magnum Geniusare transmitted to the muscles via self-adhesiveelectrodes, Axelgaard type electrodes electrodes (510K K970426) The electrodes are equivalent tothose used by the predicate.	Compex Sport" (K01180) has:Four independent channels which electrical current canbe regulated individually. Biphasic rectangular impulseswith electrical mean equal to zeroMaximum output current is 100 mA and maximumvoltage output is 200 volts. The device gives 50V outputat 500 Ohms overload and 200 volts at 10K Ohmsoverload. Maximum quantity of electricity per channel: 40µC impulse width: 200 or 400 µS. Range of pulsefrequency: 1-120 Hz The electrical pulses generated by'Compex® Sport" are transmitted to the muscles via self-adhesive electrodes.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Ion Magnum Genius is a Muscle stimulator withsix independent channels which electricalcurrent can be regulated individuallyBiphasic rectangular impulses with electrical meanequal to zero. Maximum output current is 100 mAand maximum voltage output is 200 volts. Thedevice gives 50V output at 500 Ohms overload and200 volts at 10K Ohms overload. Maximumquantity of electricity per channel:40 µC Impulsewidth: 400 to 500 µsecs. The three Ion MagnumGenius frequencies, 90 Hz, 100 and 120Hz arewithin the same range as the predicate. Theelectrical pulses generated by the Ion Magnum Geniusare transmitted to the muscles via self-adhesiveelectrodes, Axelgaard type electrodes electrodes (510K K970426) The electrodes are equivalent tothose used by the predicate.

Compex Sport" (K01180) has:Four independent channels which electrical current canbe regulated individually. Biphasic rectangular impulseswith electrical mean equal to zeroMaximum output current is 100 mA and maximumvoltage output is 200 volts. The device gives 50V outputat 500 Ohms overload and 200 volts at 10K Ohmsoverload. Maximum quantity of electricity per channel: 40µC impulse width: 200 or 400 µS. Range of pulsefrequency: 1-120 Hz The electrical pulses generated by'Compex® Sport" are transmitted to the muscles via self-adhesive electrodes.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Other equivalence aspects between lon Magnum Genius and the Predicate

Otherequivalenceaspectsbetween IonMagnumGenius andthe Predicate	1. Ion Magnum Genius and the predicate devices are identical in terms of thethermal safety (there is no thermal energy for Ion Magnum Genius or thepredicate)
2. The chemical safety is equivalent (since this is applicable to neither the IonMagnum Genius nor the predicate)
3. Sterility is equivalent (since neither the Ion Magnum Genius nor the predicaterequire sterilization or are supplied sterile.)
4. The Ion Magnum Genius uses disposable pads that do not need sterilization thatare equivalent to the pads of the predicate which also do not need sterilizationbecause they are disposable.
5. Biocompatibility of the Ion Magnum disposable pads is equivalent to those of thepredicate. Biocompatibility is performed by the company from which thesedisposable pads are purchased (Axelgaard). Ion Magnum uses disposable padsitem no: SN2020 which are square 2" x 2" (5cm x 5cm) which have a 510Knumber K970426 and comply to ISO10993-5 Biological Evaluation of MedicalDevices part 5 Test for in vitro cytotoxicity & ISO10993-10. The are made byAxelgaard Manufacturing Co. LtD, 520 Industrial Way Fallbrook California 92028,USA which has a Certificate of Registration Quality Management System - ISO13485:2003 and holds certificate no FM 40363 and operates a QualityManagement System which complies with the requirements of ISO 13485: 2003for the following scope: The design and development, manufacture and

{7}------------------------------------------------

distribution of hydrogel and non-invasive electrodes: Effective date 03/11/2012- Expiry Date: 03/12/2015.]
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 lon Magnum cablesremain screwed on and attached to the device as are the cables of the predicatedevices.

distribution of hydrogel and non-invasive electrodes: Effective date 03/11/2012- Expiry Date: 03/12/2015.]

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 lon Magnum cablesremain screwed on and attached to the device as are the cables of the predicatedevices.

output specifications comparing ion Magnum Genius With THE PREDICATE DEVICES .

・

	ION MAGNUMGENIUS	Compex SportK011880
Waveform	Biphasicsynchronous	Biphasicsynchronous
Synchronous oralternating channels	synchronous	synchronous
Dimension of Device	15.5 inches length8.5 height7.5 width	Length: 142 mmWidth 99mmHeight 36mm
Weight of theDevice	8 pounds	350 g
Weight ofAccessories	4.7 pounds	95 g
Indicator Display	Yes	Yes
Low Battery	N/A	Yes
Voltage CurrentLevel	Yes	Yes
Shape	Rectangular	Rectangular
Max Output Voltage	50V @ 500 Ω	50V
Net Charge	200 V @10k Ω0.01 amperes at500 Ohms0.004 Amperes at2K ohms0.0025 Amperes at10K Ohms	200 V +/-10
Max Output Current	100 ma at 500Ohms	100 ma at 500 Ohms
Frequency (Hz)for MuscleConditioning	90 Hz100 Hz120Hz	1-120 Hz
Pulse Duration	416 - 500 µsec	200 to 400 µsec
Pulse Width	416 - 500 µsec	200 to 400 µsec
Maximum PhaseCharge	50 µC @ 500 Ω at90 and 100 Hz40 µC @ 500 Ω at120 Hz	40 µC
Maximum CurrentDensity (mA/cm2)	4 mA / cm2	4 mA/cm2
Maximum PowerDensity (W/Cm2)	0.0012 W/cm^2	0.038 W/cm^2.
Current or VoltageDriven	Current DrivenVoltage	Current DrivenVoltage
SymmetricalPhases of Waveform	Yes	Yes
RegulatedCurrent/ voltage	Regulated Voltageand RegulatedCurrent.	Constant Current Regulator /regulated current
Method of ChannelIsolation	Channels areisolated byseparatedtransformers	Channels are isolated by separatedtransformers
Self AdhesiveElectrodes AxelgaardTyoe	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.
1. 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.
1. 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.
1. 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
1. Synchronous channels
1. Maximul output voltage
1. Maximum output current
1. range of frequencies
1. Pulse Duration
1. Pulse width
1. Maximum Phase Charge
1. Maximum Current Density

{10}------------------------------------------------

Channels' method of isolation by separate transformers

. .

. . :

1 1 . Identical Electrodes

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)

.	.	11
(Divicion Sinn I		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number _ K123158 __

Page 1 of 1

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).