REVITIVE IX

K123354 · Actegy , Ltd. · IPF · Jun 28, 2013 · Physical Medicine

Device Facts

• Record ID: K123354
• Device Name: REVITIVE IX
• Applicant: Actegy , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Revitive IX is indicated for: - Relaxation of muscle spasms; . - Prevention or retardation of disuse atrophy; ● - Increasing local blood circulation; . - Muscle re-education; . - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and . - Maintaining or increasing range of motion. .

Device Story

Revitive IX is a powered muscle stimulator (NMES) used to deliver electrical stimulation to muscles via foot pads or electrode pads. It features an optional 'IsoRocker' for ankle movement during stimulation. The device is operated by the user via a remote control and interface. It transforms electrical input into biphasic pulses (20-80Hz) to induce muscle contractions. Used in home or clinical settings, it helps patients by increasing local blood circulation, preventing disuse atrophy, and aiding muscle re-education. The healthcare provider or user monitors stimulation levels (0-150V) via the display. The device includes an automatic shut-off and patient override control for safety.

Clinical Evidence

Bench testing only. Biocompatibility, electromagnetic compatibility, and safety testing were conducted. Results confirmed the device functioned as intended and met expected performance standards.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850). Materials: ABS casing, NBR footpads. Energy: 100-240V AC power adaptor. Output: Biphasic pulses, 20-80Hz, regulated voltage up to 150V. Two output channels (sole and body pads). Features: IsoRocker for ankle movement, remote control, user interface. Connectivity: Standalone. Standards: EN60601-1-2:2007, 21 CFR 898.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, or maintenance/increase of range of motion.

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

• IF 3Wave Interferential Stimulator System, Model 711 OS (K050046)
• Lifecare Garment Electrodes (K103719)

Submission Summary (Full Text)

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K 123354

# 510(k) SUMMARY Actegy's Revitive IX

# JUN 2 8 2013

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE വന

| Phone: | [phone] |
|-----------------|---------------------|
| Facsimile: | [phone] |
| Contact Person: | Josh Penny |
| Date Prepared: | June 27, 2013 |

# Name of Device and Name/Address of Sponsor

Revitive IX

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE UK

#### Common or Usual Name

Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device

#### Classification Name

Powered muscle stimulator, 21 C.F.R. § 890.5850, Product code IPF

#### Predicate Devices

IF 3Wave Interferential Stimulator System, Model 711 OS, Compex Technologies, Inc. (K050046) Lifecare Garment Electrodes, Everyway Medical Instruments Co. Ltd. (K103719)

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#### Intended Use / Indications for Use

The Revitive IX is indicated for:

- Relaxation of muscle spasms; .
- Prevention or retardation of disuse atrophy; ●
- Increasing local blood circulation; .
- Muscle re-education; .
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
- Maintaining or increasing range of motion. .

# Technological Characteristics

The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface. See the table below for a technological comparison with the predicate IF 3Wave.

Both Revitive IX and Compex IF 3Wave are mid-frequency (20-80Hz) muscle stimulator devices with biphasic pulses, and both operate in a range which balances between comfort and effective contractions. While there are minor differences in the values for certain of the technological features, the key parameters of the Revitive IX and Compex IF 3Wave are within the same range.

## Performance Data

Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted. In all instances, the Revitive IX functioned as intended and the results observed were as expected.

#### Substantial Equivalence

The Revitive IX is as safe and effective as the IF 3Wave Interferential Stimulator System and the Lifecare Garment Electrodes. The Revitive IX has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Revitive IX and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX is as safe and effective as the predicate devices. Thus, the Revitive IX is substantially equivalent.

| Basic Unit Characteristics | | |
|----------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------|
| | Compex IF 3Wave -<br>NMES mode | Revitive IX |
| 510(k) Number | K050046 | |
| Device Name, Model | IF 3Wave Model 7110S | REVITIVE IX, RIX |
| Manufacturer | Compex Technologies, Inc | Actegy Ltd |
| Power Source(s) | 3.6Vdc Lithium Ion<br>Polymer rechargeable<br>battery, 3000mAh | Power adaptor<br>Input: 100-240V, 50/60Hz,<br>0.18A.<br>Output: 5.0Vdc, 1.0A |
| Method of Line Current Isolation | Transformers isolation | Transformers isolation |
| Basic Unit Characteristics | | |
| | Compex IF 3Wave -<br>NMES mode | Revitive IX |
| Patient Leakage Current2 | | |
| Normal condition ( $\mu$ A) | <0.1 $\mu$ A (*) | Patient leakage: 6.21 $\mu$ A max<br>Enclosure leakage: 5.99 $\mu$ A max |
| Single fault condition ( $\mu$ A) | 2.4 $\mu$ A (*) | Patient leakage: 8.36 $\mu$ A max<br>Enclosure leakage: 7.95 $\mu$ A max |
| Number of Output Modes | 3 + Combo (IF/NMES) | 1 |
| Number of Output Channels | 2 | 2 (1 for sole, 1 for body pads) |
| Synchronous or Alternating? | Alternating | Alternating |
| Method of Channel Isolation | Transformer | Transformer |
| Regulated Current or Regulated Voltage? | Regulated voltage up to 150V | Regulated voltage up to 150V |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip? | No | No |
| Automatic No-Load Trip? | Yes | No |
| Automatic Shut Off? | Yes | Yes |
| Patient Override Control? | Yes | Yes |
| Indicator Display: | | |
| On/Off Status? | Yes | Yes |
| Low Battery | Yes | n/a |
| Voltage/Current Level? | Yes (0 to 100V) | Yes (0V to 150V ) |
| Timer Range (minutes) | 15 to 30 mins (NMES pre-set modes) | 1 to 60 mins |
| Compliance with Voluntary Standards? | UL 60601-1, CSA C22.2<br>No.601-1-M90 | EMDD<br>(93/42EEC),EN60601-1-<br>2:2007 |
| Compliance* with 21 CFR 898?<br>(*Becomes mandatory beginning May 9, 2000) | 21 CFR Part 898 (*) | Complies |
| Weight | 323g with battery | 1725g (not including PSU) |
| Dimensions (mm) [W x H x D] | 98.5mm x 160mm x<br>33.5mm | Ø360mm x 75mm overall<br>height |
| Housing Materials and Construction | Unknown | Casing/body ABS,<br>footpads NBR |

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(*) Refer to Compex 510(k) application K050046

:

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 28, 2013

Actegy Ltd. c/o John J. Smith, M.D., J.D. Hogan Lovells US LLP 553 13th Street NW Washington, DC 20004

Re: K123354

Trade/Device Name: Revitive IX Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: May 28, 2013 Received: May 28, 2013

Dear Dr. John Smith:

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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Page 2 - Dr. John Smith

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 [phone] or [phone] or at its Internet address

hup://www.fda.gov/MedicalDevices/Resourcesfor 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/Safety/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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known): K123354

Device Name: _ Revitive IX_

Indications For Use:

The Revitive IX device is indicated for:

- · Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy �
- Increasing local blood circulation ●
- Muscle re-education .
- Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis

AND/OR

- Maintaining or increasing range of motion .
Prescription Use × (Part 21 CFR 801 Subpart D) 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)

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(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number _ K123354

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