Compex Wireless USA
Device Facts
| Record ID | K143551 |
|---|---|
| Device Name | Compex Wireless USA |
| Applicant | Djo, LLC |
| Product Code | NGX · Physical Medicine |
| Decision Date | Apr 28, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
Device Story
Neuromuscular electrical stimulation (NMES) device; stimulates motor nerves via electrodes to induce muscle fiber contraction. System comprises remote control, 4 wireless stimulation modules, and docking station. User selects programs (Endurance, Strength, Explosive Strength, Potentiation, Recovery, Relaxation, Pre-Warmup) via remote interface; remote communicates with modules via 2.4 GHz proprietary RF protocol. Modules deliver symmetrical biphasic rectangular pulses; parameters (frequency, contraction/rest duration) determine muscle work type. Used by adults in home/non-clinical settings for muscle training/conditioning. Output intensity controlled independently per module. Benefits include improved muscle performance and recovery. Safety managed by module-level electronic circuits; includes automatic overload/no-load trips.
Clinical Evidence
Bench testing only. Includes electrical safety (AAMI/ANSI ES 60601-1), EMC (IEC 60601-1-2), wireless coexistence, and usability/human factors testing. Software verified per FDA guidance. No clinical data presented.
Technological Characteristics
NMES device; 4-channel; symmetrical biphasic rectangular waveform; 1-120 Hz frequency; 300-400 μs pulse width. Wireless 2.4 GHz ISM band communication. LiPo battery powered. Docking station for charging. Standards: IEC 60601-2-10, IEC 60601-1, IEC 62304, ISO 14971.
Indications for Use
Indicated for healthy adults to stimulate muscles to improve or facilitate muscle performance. Contraindicated for injured or disease-afflicted muscles; not for rehabilitation or physiotherapy.
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
- Compex Sport Elite (K083140)
Reference Devices
- WiTouch TENS device (K112050)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
DJO, LLC Gina Flores Regulatory Specialist 1430 Decision Street Vista, CA 92081
Re: K143551
Trade/Device Name: Compex Wireless USA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: March 25, 2015 Received: March 27, 2015
Dear Ms. Flores:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Felipe Aquel -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) K143551
Device Name Compex Wireless USA
#### Indications for Use (Describe)
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The Compex Wireless USA may therefore be considered a technique of muscle training.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## Section 5. 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(k) number is K143551.
| Submitted by: | DJO, LLC<br>1430 Decision Street<br>Vista, CA 92081 |
|------------------------|-------------------------------------------------------------|
| Contact Person: | Gina Flores<br>Regulatory Specialist<br>760-734-3161 |
| Date Summary Prepared: | April 16, 2015 |
| Trade Name: | Compex® Wireless USA |
| Classification Name: | Powered muscle stimulator (21 CFR 890.5850) |
| Product Code: | NGX, Powered muscle stimulator, for muscle<br>conditioning. |
| Regulatory Class: | Class II |
| Predicate Device: | Compex Sport Elite (k083140) |
#### Device Description:
The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
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The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.
The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.
## Intended Use:
#### Indications for Use:
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
#### Programs:
Muscle Stimulation Training Programs: The Compex Wireless USA provides four muscle stimulation training programs: Endurance, Strength, and Explosive Strength. They correspond to the type of muscle performance the athlete wishes to improve or maintain. Each of the four training programs offers five different working levels that enable the amount of work to be gradually increased.
Specialized Muscle Training Programs: The Compex Wireless USA also offers five special muscle training programs: Potentiation, Training Recovery, Competition Recovery, Muscle Relaxation, and Pre-Warmup. Their objective is to prepare muscles
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for explosive motions or to facilitate recovery after active muscle training and competition.
# Comparison to the Predicate Device:
The indications for use for the Compex Wireless USA are identical to those of the predicate device, the Compex Sport Elite. In addition, the 9 NMES programs are identical in both devices.
The technological characteristics of the two devices are very similar, but there are a few minor differences. The following tables summarize the similarities and differences between the technological characteristics of the two devices.
| Characteristic | New Device | Predicate Device | Similar/<br>Different | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------|
| 510(k) Number | K143551 | K083140 | Similar | |
| Device Name,<br>Model | Compex® Wireless USA | Compex Sport Plus<br>(currently marketed as<br>Compex Sport Elite) | Similar | |
| Manufacturer | DJO LLC | DJO LLC<br>510(k) sponsor:<br>Chattanooga Group | Similar | |
| Connection of<br>device to electrodes | Stimulation Module is<br>directly connected to the<br>custom Compex female<br>SNAP assembled in the<br>electrode. User Interface<br>(LCD and buttons) is<br>physically separated (Remote<br>Control) and communicates<br>wirelessly with up to four (4)<br>Stimulation Modules.<br>Stimulation safety remains<br>fully managed by<br>Stimulation Module<br>electronic circuit itself. | With 6-pole cables<br>including female custom<br>SNAP plugged on the<br>custom Compex female<br>SNAP assembled in the<br>electrode. Entire<br>electronic circuit for<br>four (4) Stimulation<br>Channels and User<br>Interface is combined<br>into same casing,<br>connected to the<br>electrodes with 6-pole<br>cables. | Different | |
| Power Source(s) | Remote: : Lithium Polymer<br>(LiPo)<br>rechargeable 3.7[V] /≥<br>1500[mAh]<br>Stimulation Modules:<br>Lithium Polymer (LiPo)<br>rechargeable 3.7[V] /≥<br>450[mAh] | Rechargeable Ni-Mh<br>Battery 4.6V (4 cells<br>AA=R6) | Different | |
| Method of line<br>current isolation | N/A (battery operated<br>device) | N/A (battery operated<br>device) | Similar | |
| | | | | |
| Patient Leakage Current | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| • Normal condition | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| • Single fault condition | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| Number of Output Modes | One (NMES) | One (NMES) | Similar | |
| Number of Output Channels | Four | Four | Similar | |
| Synchronous or Alternating? | Synchronous, but never 2 channels activated at the same time | Synchronous, but never 2 channels activated at the same time | Similar | |
| Method of Channel Isolation | Each channel is the middle of a H-Bridge. Except when it is activated, each channel is always in high impedance state. | Each channel is the middle of a H-Bridge. Except when it is activated, each channel is always in high impedance state. | Similar | |
| Regulated Current or Regulated Voltage? | Regulated current (all channels) | Regulated current (all channels) | Similar | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Similar | |
| Automatic Overload Trip? | Yes | Yes | Similar | |
| Automatic No-Load Trip? | Yes | Yes | Similar | |
| Automatic Shut Off? | "On/Off" switch | "On/Off" switch | Similar | |
| Patient Override Control? | Yes | Yes | Similar | |
| Indicator Display - On/Off Status? | Yes | Yes | Similar | |
| - Low Battery? | Yes | Yes | Similar | |
| - Voltage/Current Level? | Yes, unit = [Energy] | Yes, unit = [Energy] | Similar | |
| Timer Range (minutes) | Maximum = 48 minutes; Screen shows remaining time in minutes and displays image showing time remaining | Maximum = 55 minute Screen shows remaining time in minutes and seconds and displays countdown timer | Different | |
| Compliance with 21 CFR 898? | Yes | Yes | Similar | |
| Charging System | AC/DC 5[v] 3.5[A]; Distributed through docking station to remote | AC/DC 9[v] 0.4[A] Distributed directly to the device | Different | |
| and 4 modules | | | | |
| Weight | - | Remote: 110 [g]<br>- Stimulation Module:2x60 [g]<br>- Docking Station 800 [g] | 300 [g] | Different |
| Dimensions [W x H x D] | - | Remote 9x4.5x0.7[cm]<br>- Stimulation Module: 6.5x2 [cm]<br>- Docking Station: 25x25x2 [cm] | 99 x 142 x 36 [mm]<br>3.9 x 5.6 x 1.4 [in] | Different |
# Basic Device Characteristics – Comparison with Predicate Device
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## Output Specifications – Comparison with Predicate Device
| Characteristic | New Device | Predicate Device | Similar/Different |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-------------------|
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Similar |
| Shape | Rectangular | Rectangular | Similar |
| Maximum Output<br>Voltage (± 10%) | 60 V @ 500 Ω<br>180 V @ 2 kΩ<br>180 V @ 10 kΩ | 60 V @ 500 Ω<br>165 V @ 2 kΩ<br>165 V @ 10 kΩ | Different |
| Maximum Output<br>Current (± 10%) | 120 mA @ 500 Ω<br>90 mA @ 2 kΩ<br>18 mA @ 10 kΩ | 120 mA @ 500 Ω<br>82 mA @ 2 kΩ<br>16 mA @ 10 kΩ | Different |
| Pulse Width | 300 to 400 [μs]<br>(microseconds) | 200 to 400 [μs]<br>(microseconds) | Different |
| Frequency | 1 to 120 Hz | 1 to 120 Hz | Similar |
| For multiphasic<br>waveforms only:<br>- Symmetrical<br>phases?<br>- Phase Duration<br>(include units)<br>(state range, if<br>applicable) (both<br>phases, if<br>asymmetrical) | Symmetrical, 300 - 400 μs | Symmetrical, 200 - 400 μs | Different |
| Net Charge<br>[μC/pulse] | 0 [μC] @ 500Ω<br>Excitation pulse fully<br>compensated | 0 [μC] @ 500Ω<br>Excitation pulse fully<br>compensated | Similar |
| Maximum Phase<br>Charge [μC] | 48 [μC] @ 500Ω | 48 [μC] @ 500Ω | Similar |
| Maximum Current<br>(RMS) Density<br>[mA/cm²] | 1.49 [mA/cm²] @ 500Ω | 1.49 [mA/cm²] @ 500Ω | Similar |
| Maximum Power<br>Density [mW/cm²] | 27.6 [mW/cm²] @500Ω | 27.6 [mW/cm²] @500Ω | Similar |
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Although there are minor differences in the maximum output voltage and current, the physical dimensions, the timer range, the batteries used as a power source, and the battery charging specifications, the most significant difference between the two devices is the connection of the device to the electrodes. The Compex Wireless USA uses wireless technology, whereas the predicate device uses 6-pole cables. This type of wireless technology is used in other OTC devices, such as the WiTouch TENS device (k1120500). None of these differences, including the use of wireless technology, raise any new issues of safety or effectiveness.
# Performance Testing:
Electrical Safety and Electromagnetic Compatibility: The Compex Wireless USA was tested and found to comply with recognized standards for electrical safety and electromagnetic compatibility.
FCC Radio Frequency Testing: The Compex Wireless USA was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249.
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.
Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.
Wireless Coexistence Testing: The performance of Compex Wireless USA was evaluated in an environment with other Compex Wireless USA device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.
# Standards:
| Designation | Name | FDA Recognition |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------|
| AAMI/ANSI ES 60601-<br>1:2005(R)2012 and C1:2009/(R)2012<br>and A2:2010/(R)2012 (Consolidated<br>Text).<br>Compex Wireless USA device | Medical Electrical Equipment – Part 1:<br>General Requirements for Basic Safety<br>and Essential Performance | 19-5 |
| IEC 60950-1:2005 (2nd Ed.):<br>Docking Station Only | Information Technology Equipment –<br>Safety - Part 1: General requirements | N/A |
The Compex Wireless USA conforms to the following standards.
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| IEC 60601-1-2 Ed. 3:2007-03:<br>Compex Wireless USA device | Medical Electrical Equipment - Part 1-2:<br>General Requirements for Basic Safety<br>and Essential Performance - Collateral<br>Standard: Electromagnetic Compatibility<br>– Requirements and Tests | 19-1 |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| EN 55022:2010/AC:2011<br>Docking Station only | Information Technology Equipment –<br>Radio Disturbance Characteristics –<br>Limits and Methods of Measurement | N/A |
| EN 55024:2010<br>Docking Station only | Information Technology Equipment –<br>Immunity Characteristics – Limits and<br>Methods of Measurement | N/A |
| EN 61000-3-2:2006 +A1:2009<br>+A2:2009<br>Docking Station only | Electromagnetic Compatibility (EMC) –<br>Part 3.2: Limits – Limits for Harmonic<br>Current Emissions (Equipment Input<br>Current Less Than or Equal To 16 A per<br>Phase). | N/A |
| EN 61000-3-3:2013<br>Docking Station only | Electromagnetic Compatibility (EMC) –<br>Part 3.3: Limits - Limitation of Voltage<br>Changes, Voltage Fluctuations and<br>Flicker in Public Low-Voltage Supply<br>Systems, for Equipment with Rated<br>Current Less Than or Equal To 16 A per<br>Phase and Not Subject to Conditional<br>Connection | N/A |
| IEC 60601-1-6 Ed. 3.0: 2010-01 | Medical Electrical Equipment - Part 1-6:<br>General Requirements for Basic Safety<br>and Essential Performance - Collateral<br>Standard: Usability | 5-85 |
| IEC 60601-1-11 Ed. 1.0: 2010-04 | Medical Electrical Equipment – Part 1-<br>11: General Requirements - Collateral<br>Standard: Requirements for Medical<br>Electrical Equipment and Medical<br>Electrical Systems Used in the Home<br>Healthcare Environment | 19-6 |
| IEC 60601-2-10 Ed. 2.0 2012-06 | Medical Electrical Equipment – Part 2-<br>10: Particular Requirements for the<br>Basic Safety and Essential Performance<br>of Nerve and Muscle Stimulators | 17-11 |
| IEC 62366:2007 | Medical Devices – Application of<br>Usability Engineering to Medical<br>Devices | N/A |
| AAMI/ANSI HE75:2009 | Human Factors Engineering – Design of<br>Medical Devices | 5-57 |
| ISO 14971:2007 | Medical Devices – Application of Risk<br>Management to Medical Devices | 5-40 |
| IEC 62304 First Ed. 2006-05 | Medical Device Software - Software<br>Life Cycle Processes | 13-8 |
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## Conclusion:
Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Compex Wireless USA is as safe and effective as, and substantially equivalent to, the predicate device.
