Chattanooga Revolution Wireless

K153696 · Djo, LLC · IPF · Apr 14, 2016 · Physical Medicine

Device Facts

• Record ID: K153696
• Device Name: Chattanooga Revolution Wireless
• Applicant: Djo, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional. Indications for Use: As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain As a pulsed mode device, indications are for the following conditions: - Relaxation of muscle spasm - Increasing local blood circulation - Retardation or prevention of disuse atrophy - Maintenance or increase of range of motion

Device Story

Chattanooga Revolution Wireless is a clinical NMES/TENS electrotherapy system. System comprises a remote control, 4 independent stimulation modules, and electrodes, stored in a docking station. Remote control interfaces with user to select programs and control stimulation intensity; communicates with modules via proprietary 2.4 GHz ISM band wireless protocol. Modules deliver electrical impulses to motor nerves via snap gel electrodes to induce muscle response or provide pain relief. Used in clinics, hospitals, nursing homes, and chiropractic offices by healthcare professionals. Output parameters (frequency, pulse width, contraction/rest times) are adjustable to achieve specific therapeutic goals like muscle pumping or atrophy prevention. Wireless design eliminates cables between remote and modules; modules are battery-powered. Output affects clinical decision-making by providing targeted muscle stimulation or pain management, potentially improving patient mobility and recovery.

Clinical Evidence

Bench testing only. No clinical data. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), wireless coexistence, software verification (IEC 62304), and usability/human factors (IEC 62366).

Technological Characteristics

Battery-powered (LiPo 3.7V) NMES/TENS device. 4 independent stimulation modules communicating via 2.4 GHz proprietary RF protocol. Output: Symmetrical biphasic rectangular waveforms (VMS, VMS-FR). Compliance with AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62304, ISO 14971. Features automatic no-load trip and shut-off.

Indications for Use

Indicated for adult patients requiring NMES for disuse atrophy, ROM maintenance, muscle re-education, spasm relaxation, blood circulation, or DVT prevention; or TENS for chronic intractable, post-surgical, or post-trauma pain management. Used under supervision of a healthcare professional.

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

• Vectra Neo (K132284)

Reference Devices

• Compex Wireless USA (K143551)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2016

DJO, LLC Lorri Trotter Regulatory Affairs Manager 1430 Decision Street Vista. California 92081

Re: K153696

Trade/Device Name: Chattanooga Revolution Wireless Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF; GZJ Dated: March 11, 2016 Received: March 14, 2016

Dear Ms. Trotter:

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

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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 devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J.Hoffmann -A

- 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) K153696

#### Device Name Chattanooga Revolution Wireless

Indications for Use (Describe)

The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.

Indications for Use:

As an NMES device, indications are for the following conditions:

- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery

As a TENS device, indications are for the following conditions:

- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain

As a pulsed mode device, indications are for the following conditions:

- Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

| Submitted by: | DJO, LLC |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | 1430 Decision Street |
| | Vista, CA 92081 |
| Contact Person: | Lorri Trotter |
| | Regulatory Affairs Manager |
| | [phone] |
| Date Summary Prepared: | April 11, 2016 |
| Trade Name: | Chattanooga® Revolution Wireless |
| Classification Name: | Powered muscle stimulator (21 CFR 890.5850);<br>Transcutaneous electrical nerve stimulator for pain relief<br>(21 CFR 5890) |
| Product Code: | IPF, GZJ |
| Regulatory Class: | Class II |
| Predicate Device: | Vectra Neo (K132284) |

#### Device Description:

The Chattanooga Revolution Wireless 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 Chattanooga "Revolution Wireless 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 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.

The Chattanooga® Revolution Wireless 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

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electrical connection (cable). Two proprietary 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 docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.

The wireless protocol of the Chattanooga® Revolution Wireless 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.

## Indications for Use:

The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.

Indications for Use:

As an NMES device, indications are for the following conditions:

- Retarding or preventing disuse atrophy -
- -Maintaining or increasing range of motion
- Re-educating muscles -
- Relaxation of muscle spasms -
- -Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery -

As a TENS device, indications are for the following conditions:

- Symptomatic relief and management of chronic, intractable pain -
- Post-surgical and post-trauma acute pain -
- As a pulsed mode device, indications are for the following conditions:
- Relaxation of muscle spasm -
- Increasing local blood circulation -
- -Retardation or prevention of disuse atrophy
- Maintenance or increase of range of motion -

#### Programs:

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The Chattanooga Revolution Wireless provides 14 programs: Trigger Point, Acute Pain, Chronic Pain, Muscle Pump Cycle, Muscle Pump Continuous, Increase ROM (Range of Motion), Decrease Muscle Tone, Fast Twitch Function, Muscle Atrophy, Slow Twitch Function, VMS-FR Dynamic 2 Channel, VMS-FR Dynamic 4 Channel, VMS-FR Static 2 Channel, and VMS-FR Static 4 Channel.

## Comparison to the Predicate Device: Includes Table

The indications for use for the Revolution Wireless USA are a subset of those for the predicate device the Vectra Neo Clinical Therapy System. The predicate device has additional features, functions, and applications that are not included in the Revolution Wireless. Therefore, we are comparing the Revolution Wireless only to those functions of the predicate that are applicable.

The technological characteristics of the two devices are very similar for the comparable functions, but there are a few differences. The following table summarizes the similarities and differences between the technological characteristics of the two devices. The power sources of the two devices differ (Revolution is battery powered) and output specifications differ slightly between the two devices, but the Chattanooga Revolution Wireless conforms to required standards, and small differences in output do not raise any issues of safety or effectiveness. The Revolution Wireless differs from the predicate in that it communicates wirelessly with the stimulation modules, but the design of the wireless feature is identical to that of the Compex Wireless USA (k143551).

| Basic Device Characteristics – Comparison with Predicate Device | | | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Characteristic | New Device | Predicate Device | Similar/ Different |
| 510(K) Number<br>Device Name, Model | Chattanooga<br>Wireless PRO | K132284<br>Vectra Neo Clinical<br>Therapy System | Different |
| Manufacturer | DJO, LLC | DJO, LLC | Similar |
| Prescription/OTC | Prescription | Prescription | Similar |
| Where used | Physician office,<br>physical therapy<br>Clinic, Hospital,<br>Nursing Home, Post<br>Acute Care,<br>Chiropractic Clinic | Physician office,<br>physical therapy<br>Clinic, Hospital,<br>Nursing Home, Post<br>Acute Care,<br>Chiropractic Clinic | Similar |
| Target population | Adult Population | Adult Population | Similar |
| Anatomical library | Yes | Yes | Similar |
| Audio Indicator | Yes | Yes | Similar |
| Connection of device to electrodes | Stimulation Module<br>is directly connected<br>to the custom male<br>SNAP assembled in<br>the electrode. User<br>Interface (LCD and<br>buttons) is physically<br>separated (Remote | With cables<br>including pins to<br>connect to electrodes<br>pins. There is 1 cable<br>per channel with a<br>maximum of 4<br>channels | Different |
| Characteristic | New Device | Predicate Device | Similar/Different |
| | Control) and<br>communicates<br>wirelessly with up to<br>four (4) stimulation<br>modules.<br>Stimulation safety<br>remains fully<br>managed by<br>Stimulation Module<br>electronic circuit<br>itself. | | |
| Power Source (s) | Rechargeable battery | 100-240V~, 2.6-<br>1.0A, 47-63Hz | Different |
| Method of Line Current Isolation | NA<br>Battery operated<br>device | Independent<br>transformer isolated | Different |
| Electrical Type | NA<br>Battery operated<br>device | Type BF | Different |
| Patient Leakage Current - Normal<br>Condition (μΑ) | NA<br>Battery operated<br>device | <100uA patient<br>leakage | Different |
| Patient Leakage Current - Single<br>Fault Condition (μΑ) | NA<br>Battery operated<br>device | <300uA line leakage | Different |
| Number of Output Modes | Muscle stimulator:<br>Electrodes | Muscle stimulator:<br>Electrodes<br>Ultrasound:<br>applicators<br>EMG:electrodes<br>Laser: applicator | Different |
| Number of Output Channels | 4 | 0, 2, or 4 | Similar |
| Synchronous or Alternating | See Output<br>Specifications Below | See Output<br>Specifications Below | |
| Method of Channel Isolation | Each channel is the<br>middle of a H Bridge.<br>Except when it is<br>activated, each<br>channel is always in<br>high impedance state | Through<br>transformers and<br>opto-couplers | Different |
| Regulated Current or Regulated<br>Voltage (output signals only) | Regulated current on<br>all channels | Configurable for<br>either constant<br>voltage or constant<br>current, see Output<br>Specifications below. | Similar |
| Software/Firmware/Microprocessor<br>Control | Yes | Yes | Similar |
| Characteristic | New Device | Predicate Device | Similar/<br>Different |
| Automatic No-Load Trip | Yes | Yes | Similar |
| Automatic Shut Off | Yes, On/off switch | Yes | Similar |
| Patient Override Control | Yes | Yes | Similar |
| Indicator Display | | | Similar |
| - On/Off Status | Yes | Yes | |
| - Low Battery | Yes | No battery | |
| - Voltage/Current level? | Yes, unit [mili<br>Amps] | Yes, unit [mA] | |
| Timer Range (Minutes) | Yes, unit [minutes]<br>Max 30 [minutes] | 0-60 [minutes] | Different |
| Compliance with 21 CFR 898? | Yes<br>21CFR 898-<br>Performance standard<br>for electrode lead<br>wires and patient<br>cables. | 21CFR 898-<br>Performance<br>standard for<br>electrode lead wires<br>and patient cables. | Similar |
| Weight | Remote: 0.24 lbs<br>with battery | Device: 20.7 lbs | Different |
| | Stimulation Module:<br>0.11 lbs per module | Module: 1 lbs | Different |
| | Docking Station: 3<br>lbs | Device + Cart<br>Accessory: 48.9 lbs | Different |
| Dimension (in.) [W x H x D] | Remote: 11 x 7 x 2<br>cm | Device: [15.89 x<br>20.05 x 15.89] | Different |
| | Stimulation Module:<br>2x(6 x 2) cm | Module: [11.12 x<br>1.43 x 6.34] | Different |
| | Docking Station<br>tablet: 14x27x3 [cm] | Device + Cart:<br>[23.94 x 52.85 x<br>26.19] | Different |
| OUTPUT SPECIFICATIONS | | | |
| VMS Symmetrical Biphasic Waveform | | | |
| Shape | Rectangular | Rectangular | Similar |
| Maximum Output Voltage (± 10%) | 60 V @ 500 Ω<br>180V @ 2 kΩ<br>180 V @ 10 kΩ | 57 V @ 500 Ω<br>200 V @ 2 kΩ<br>100V @ 10 kΩ<br>(open lead detected<br>above 10[mA]) | Different |
| Maximum Output Current (± 10%) | 120 mA @ 500 Ω<br>90 mA @ 2 kΩ<br>18 mA @ 10 kΩ | 114 mA @ 500 Ω<br>100 mA @ 2 kΩ<br>10 mA @ 10 kΩ<br>(open lead detected<br>above 10[mA]) | Different |
| Pulse Width | 300 to 400 [μs]<br>(microseconds) | 20 to 400 [μs]<br>(microseconds) | Different |
| Frequency | 1 to 100 Hz | 1 - 200 [Hz] | Different |
| Net Charge [μC/pulse] | 0 [μC] @ 500Ω<br>Excitation pulse fully<br>compensated | 0 [μC] @ 500Ω | Similar |
| Characteristic | New Device | Predicate Device | Similar/<br>Different |
| Maximum Phase Charge [µC] | 48 [µC] @ 500Ω | 45.6 [µC] @ 500Ω | Different |
| Maximum Current (RMS) Density<br>(mA/cm2) | 2.1mA/cm2 | 2.4 mA/cm2 | Different |
| Maximum Power Density<br>[mW/cm²] | 36 [mW/cm²] @ 500Ω | 55 [mW/cm²] @ 500Ω | Different |
| ON Time (seconds) | 1 - 10 [sec] | 1 - 60 [sec] | Different |
| OFF Time (seconds) | 3 - 50 [sec] | 1 - 60 [sec] | Different |
| Additional Features (if applicable) | 100 [µs]<br>(microseconds) | 100 [µs]<br>(microseconds) | Similar |
| VMS-FR Waveform | | | |
| Shape | Rectangular | Rectangular | Similar |
| Maximum Output Voltage (± 10%) | 60 V @ 500 Ω<br>180V @ 2 kΩ<br>180 V @ 10 kΩ | 57 V @ 500 Ω<br>200 V @ 2 kΩ<br>100V @ 10 kΩ<br>(open lead detected above 10[mA]) | Different |
| Maximum Output Current (± 10%) | 120 mA @ 500 Ω<br>90 mA @ 2 kΩ<br>18 mA @ 10 kΩ | 114 mA @ 500 Ω<br>100 mA @ 2 kΩ<br>10 mA @ 10 kΩ<br>(open lead detected above 10[mA]) | Different |
| Pulse Width | 200 to 300 [µs]<br>(microseconds) | 20 to 400 [µs]<br>(microseconds) | Different |
| Frequency | 35 - 80 Hz | 20 - 80 [Hz] | Different |
| Net Charge [µC/pulse] | 0 [µC] @ 500Ω<br>Excitation pulse fully<br>compensated | 0 [µC] @ 500Ω | Similar |
| Maximum Phase Charge [µC] | 36 [µC] @ 500Ω | 45.6 [µC] @ 500Ω | Different |
| Maximum Current (RMS) Density<br>(mA/cm2) | 1.34mA/cm2 | 1.52 mA/cm2 | Different |
| Maximum Power Density<br>[mW/cm²] | 14.4 [mW/cm²] @ 500Ω | 22 [mW/cm²] @ 500Ω | Different |
| Burst Mode (i.e. pulse trains) | N/A, no burst mode<br>a) Pulses per burst<br>b) Bursts per second<br>c) Burst duration (seconds)<br>d) Duty Cycle<br>[Line (b) x Line (c)] | VMS burst | Different |
| ON Time (seconds) | 1 - 10 [sec] | 1 - 60 [sec] | Different |
| OFF Time (seconds) | 3 - 50 [sec] | 1 - 60 [sec] | Different |
| Additional Features (if applicable) | 100 [µs]<br>(microseconds) | 100 [µs]<br>(microseconds) | Similar |
| Interphase interval | (microseconds) | (microseconds) | |

## Rasic Device Characteristics - Comparison with Predicate Device

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## Performance Testing:

Electrical Safety and Electromagnetic Compatibility: The Chattanooga® Revolution Wireless was tested and found to comply with recognized standards for electrical safety and electromagnetic compatibility.

FCC Radio Frequency Testing: The Chattanooga® Revolution Wireless 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 Chattanooga® Revolution Wireless was evaluated in an environment with other Chattanooga® Revolution Wireless device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.

#### Standards:

| Recognition<br>No. | Standard | Description |
|--------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | AAMI/ANSI ES60601-<br>1:2005/(R)2012 And A1:2012,<br>C1:2009/(R)2012 And<br>A2:2010/(R)2012 (Consolidated<br>Text) | Medical Electrical Equipment - Part<br>1: General Requirements for Basic<br>Safety and Essential Performance<br>(IEC 60601-1, Mod.) |
| 19-1 | IEC 60601-1-2 Edition 3:2007-03 | Medical Electrical Equipment - Part<br>1-2: General Requirements for Basic<br>Safety and Essential Performance –<br>Collateral Standard: Electromagnetic<br>Compatibility – Requirements and<br>Tests |
| 17-11 | IEC 60601-2-10 Edition 2.0 2012-<br>06 | Medical Electrical Equipment -- Part<br>2-10: Particular Requirements for<br>the Basic Safety and Essential<br>Performance of Nerve and Muscle<br>Stimulators |
| 5-85 | IEC 60601-1-6 Edition 3.0 2010-01 | Medical Electrical Equipment - Part |

The Chattanooga Revolution Wireless conforms to the following standards.

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| | | 1-6: General Requirements for Basic<br>Safety and Essential Performance –<br>Collateral Standard: Usability |
|------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| N/A* | IEC 62366:2007, Ed. 1<br>* Ed. 1 was used because it is cited<br>in IEC 60601-1-6 Ed. 3.0. | Medical Devices - Application of<br>Usability Engineering to Medical<br>Devices |
| 13-8 | IEC 62304 First Edition 2006-05 | Medical Device Software - Software<br>Life Cycle Processes |
| 5-40 | ISO 14971:2007 | Medical Devices - Application of<br>Risk Management to Medical<br>Devices |

## Conclusion:

Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Chattanooga Revolution Wireless is as safe and effective as, and substantially equivalent to, the predicate device.