Body System

K182440 · A-1 Engineering · NGX · Feb 26, 2019 · Physical Medicine

Device Facts

• Record ID: K182440
• Device Name: Body System
• Applicant: A-1 Engineering
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Body System is intended for muscle conditioning to stimulate healthy muscles. The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.

Device Story

Body System (models SX101, OS2911) is a powered muscle stimulator for muscle conditioning; utilizes 16 channel ports with self-adhesive pad applicators. Device delivers electrical currents to contract muscles; features manual adjustment of five frequency programs (200 Hz to 1250 Hz). Output signal is biphasic, rectangular, voltage and current regulated; channels are isolated via separate transformers. Operated by trained professional in clinical setting; professional monitors treatment. Device powered by 110-240V AC mains. Output parameters (voltage, current, frequency) adjusted manually; display shows treatment time. Benefits include muscle conditioning through electrical stimulation of healthy muscle tissue.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993), output waveform analysis, electromagnetic compatibility (EN/IEC 60601-1-2), and electrical safety (IEC 60601-1).

Technological Characteristics

Powered muscle stimulator; aluminum housing. 16 isolated channels; biphasic, rectangular waveform. Frequency: 200-1250 Hz; Pulse width: 500-2500 µsec. Max output: 88V @ 2kΩ. Power: 110-240V AC, 50-60Hz. Electrical safety: IEC 60601-1, IEC 60601-2-10. EMC: IEC 60601-1-2. Biocompatibility: ISO 10993-5, ISO 10993-10. Non-software controlled (manual adjustment).

Indications for Use

Indicated for muscle conditioning to stimulate healthy muscles in adults. Contraindicated for use in conjunction with therapy or treatment of medical diseases or conditions of any kind; not for use on injured or ailing muscles.

Regulatory Classification

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.

Predicate Devices

• Ion Magnum Genius (K123158)
• Compex Wireless USA (K143551)

Submission Summary (Full Text)

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February 26, 2019

A-1 Engineering % Peter Knauer Principal Consultant Sage BioPartners 1741 Little Kate Rd Park City, Utah 84060

Re: K182440

Trade/Device Name: Body System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 26, 2018 Received: November 27, 2018

Dear Peter Knauer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182440

Device Name Body System

Indications for Use (Describe)

The Body System is intended for muscle conditioning to stimulate healthy muscles.

The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span style="margin-right:5px;"><input type="checkbox"/></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# Section 5. 510(k) Summary / Statement - 21 CFR 807.92(a)

This 510(k) Summary for the Body System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.

| Applicant Name: | A-1 Engineering |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Address: | 30 Mauchly, Suite A<br>Irvine, CA 92618 |
| Official Contact: | Tony Picciano, Owner |
| Telephone: | [phone] |
| Email: | [e-mail] |
| Submission Date: | November 26, 2018 |
| Subject Device: | Trade Name: Body System<br>Common Name: Muscle stimulator for conditioning. |
| Regulation Description: | Powdered Muscle Stimulator |
| Classification: | Regulatory Class II, 21 CFR 890.5850 |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Product Code: | NGX |
| Device Description | Body System (available in models: SX101 and OS2911). Both models<br>utilize the same internal electrical components. The models differ only in<br>the control/display features and exterior casing/dimensions. The Body |

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System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.

The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.

The Intended Use of the Body System has the same key elements as the predicates: for muscle conditioning to stimulate healthy muscle. There are no differences in Intended Use amongst the predicates.

- The Body System is intended for muscle conditioning to stimulate healthy Indications for use: muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body Sy is intended to be operated by a trained professional who is present to monit treatment.

- Predicate Device: The Body System is substantially equivalent to the predicate devices listed below:
- . K123158, Ion Magnum Genius, under 21 CFR 890.5850 and Product Code NGX

Predicate Trade Name: Ion Magnum Genius

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Conditioning Premarket Notification: K123158 Manufacturer: Ion Genius, Inc. . K143551, Compex Wireless USA, under 21 CFR 890.5850 and Product Code NGX Predicate Trade Name: Compex Wireless USA Classification Name: Stimulator, Muscle, Powered for Muscle Conditioning Premarket Notification: K143551 Manufacturer: DJO, LLC Based on the intended use/Indications for use, design, materials, principle of operation, energy used and materials, the Body System is substantially equivalent to the legally marketed predicate devices. The non-clinical performance data demonstrates substantial equivalence and includes an analysis of output waveforms. Non-Clinical Tests The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Device: ● Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass . Biocompatibility – irritation (ISO-10993-10) – result: Pass ● Biocompatibility - Sensitization (ISO-10993-10) - result: Pass . Performance – including Output Waveforms of the Body System as compared to a predicate . Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016 . Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Summary: There are no differences in the technological characteristics between the subject device and the predicate devices, which raise issues concerning safety, performance or efficacy. The Body System is substantially equivalent to the predicate device(s) in terms of safety and effectiveness.

Classification Name: Stimulator, Muscle, Powered for Muscle

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| Comparison of the Subject and Predicate Devices | | | | | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Elements of<br>Comparison | Subject device | Primary<br>Predicate Device | Secondary<br>Predicate Device | Similar/Different | |
| Device Name and<br>Model | Body System | Ion Magnum<br>Genius | Compex Wireless<br>USA | N/A | |
| 510 (K) Number | Subject of this<br>submission | K123158 | K143551 | N/A | |
| Product Code | NGX | NGX | NGX | Similar | |
| Regulation<br>Number | 890.5850 | 890.5850 | 890.5850 | Similar | |
| Indications for<br>Use | The Body System<br>is intended for<br>muscle<br>conditioning to<br>stimulate healthy<br>muscles.<br><br>The Body System<br>is not intended to<br>be used in<br>conjunction with<br>therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. The Body<br>System is<br>intended to be<br>operated by a<br>trained<br>professional who<br>is present to<br>monitor<br>treatment. | Ion Magnum<br>Genius is<br>intended for<br>muscle<br>conditioning to<br>stimulate healthy<br>muscles. The Ion<br>Magnum Genius<br>is not intended to<br>be used in<br>conjunction with<br>therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. None of the<br>Ion Magnum<br>Genius programs<br>is designed for<br>injured or ailing<br>muscles and its<br>use on such<br>muscles is<br>contraindicated.<br>The Ion Magnum | The Compex<br>Wireless USA is an<br>Over-The-Counter<br>device intended<br>to stimulate<br>healthy muscles in<br>order to improve<br>or facilitate<br>muscle<br>performance. It is<br>to be used by<br>adults only.<br><br>The Compex<br>Wireless USA is<br>not intended for<br>adjunctive<br>therapy in the<br>treatment of<br>medical diseases<br>and conditions of<br>any kind. None of<br>the Compex<br>Wireless USA<br>stimulation<br>programs are<br>designed for<br>injured or disease<br>afflicted muscles.<br>Its use on such | Similar - although<br>there are some<br>differences in the<br>exact language of<br>each Intended<br>Use, each is<br>indicated for the<br>Stimulation of<br>Healthy Muscles | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of<br>Comparison | Subject device | Primary<br>Predicate Device | Secondary<br>Predicate Device | Similar/Different | |
| | | offered under<br>prescription given<br>by a physician<br>licensed in the<br>state in which he<br>or she practices. | contraindicated.<br>The work imposed<br>on the muscles by<br>the Compex<br>Wireless USA<br>programs is<br>definitely not<br>suitable for<br>rehabilitation and<br>physiotherapy.<br>The Compex<br>Wireless USA<br>electrical impulses<br>allow the<br>triggering of<br>action potentials<br>on motoneurones<br>of motor nerves<br>(excitations).<br>These excitations<br>of motoneurones<br>are transmitted to<br>the muscle fibers<br>via the motor<br>endplate where<br>they generate<br>mechanical<br>muscle fiber<br>responses that<br>correspond to<br>muscle work.<br>Depending on the<br>parameters of the<br>electrical impulses<br>(pulse frequency,<br>duration of<br>contraction,<br>duration of rest,<br>total session<br>duration),<br>different types of | | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of<br>Comparison | Subject device | Primary<br>Predicate Device | Secondary<br>Predicate Device | Similar/Different | |
| | | | be imposed on<br>the stimulated<br>muscles.<br>The Compex<br>Wireless USA may<br>therefore be<br>considered a<br>technique of<br>muscle training. | | |
| Body Application<br>Areas | Body | Body | Body | Similar | |
| Power Sources | 110vac — 240 vac<br>(AC wall plug-In) | 110vac — 240 vac<br>(AC wall plug-In) | Lithium Polymer<br>(LiPo)<br>rechargeable<br>batteries | Different -<br>differences do not<br>present different<br>questions of/or<br>effect safety and<br>effectiveness; the<br>similar currents<br>generated by<br>each channel and<br>applied to the<br>patient is isolated<br>from the power<br>source. | |
| Patient Leakage<br>Current | 0.05 µA and | 0.07 μΑ | N/A | Similar | |
| Number of<br>Output Modes for<br>Micro current<br>Stimulation | 5 | 3 | 1 | Different -<br>differences do not<br>present different<br>questions of/or<br>effect safety and | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of<br>Comparison | Subject device | Primary<br>Predicate Device | Secondary<br>Predicate Device | Similar/Different | |
| | | | | effectiveness; all<br>outputs meet the<br>requirements of<br>the FDA Guidance<br>on Powered<br>Muscle<br>Stimulators. | |
| Number of<br>Channels for<br>Micro current<br>Stimulation | 16 | 6 | 4 | Different -<br>differences do not<br>present different<br>questions of/or<br>effect safety and<br>effectiveness;; all<br>channels are<br>isolated and<br>generate the<br>identical signal,<br>which are similar<br>to the predicates. | |
| Channel Output:<br>Synchronous or<br>Alternating | Synchronous | Synchronous | Synchronous | Similar | |
| Channel Output:<br>Method of Line<br>Current Isolation | Power Supply<br>isolation | Power Supply<br>isolation | Power Supply<br>isolation | Similar | |
| Regulated<br>Current or<br>Regulated<br>Voltage | Both | Voltage | Both | Similar (voltage<br>regulated devices) | |
| Software/Firm<br>ware/Microproce<br>ssor control | No | No | Yes | Different -<br>differences do not<br>present different<br>questions of/or | |
| Comparison of the Subject and Predicate Devices | | | | | |
| Elements of<br>Comparison | Subject device | Primary<br>Predicate Device | Secondary<br>Predicate Device | Similar/Different | |
| | | | | effect safety and<br>effectiveness; the<br>similar currents<br>generated by<br>each unit is not<br>related to<br>software/<br>firmware. | |
| Automatic<br>Overload Trip | Yes | Yes | Yes | Similar | |
| Automatic No<br>load Trip | Yes | Yes | Yes | Similar | |
| Indicator Display:<br>On / Off Status | Yes | Yes…