Revitive IX (OTC)

K143207 · Actegy , Ltd. · NGX · Mar 23, 2015 · Physical Medicine

Device Facts

• Record ID: K143207
• Device Name: Revitive IX (OTC)
• Applicant: Actegy , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Mar 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.

Device Story

Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device for home use. It delivers electrical impulses via conductive foot pads or self-adhesive electrode pads to stimulate muscle tissue, causing artificial contraction. Features include an optional IsoRocker™ for ankle movement during stimulation and a remote control. Input consists of user-selected intensity (1-99) and treatment duration (1-60 minutes). Device transforms electrical power into pulsed symmetrical biphasic, rectangular, and bipolar waveforms. Healthcare providers do not operate the device; it is for patient self-use. Output is muscle stimulation, which patients use to increase local blood circulation, improve muscle performance, and relieve pain from strain. Benefits include non-invasive pain management and muscle conditioning in a home setting.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing (biocompatibility per ISO 10993-5/10, electrical safety/EMC per BS EN 60601 series) and a summative usability study following FDA human factors guidance. Usability study confirmed intended users can safely and effectively operate the device in a home environment.

Technological Characteristics

Mid-frequency (20-53Hz) NMES; pulsed symmetrical biphasic, rectangular, and bipolar waveforms. Output: 10-14mA@500Ω r.m.s., max 32V@500Ω. Materials: ABS plastic housing, conductive NBR footpads, carbon film/hydrogel electrodes. Power: 5V DC adapter. Features: IsoRocker, 1-99 intensity steps, 1-60 min timer. Non-sterile. Software-controlled pulse generation.

Indications for Use

Indicated for: temporarily increasing local blood circulation in healthy leg muscles; stimulating healthy muscles to improve/facilitate muscle performance; temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or normal household duties.

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

• OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965)
• Prospera OTC TENS Electronic Pulse Massager - PL009 (K122744)
• Revitive IX (RX), Model: RIX Actegy Ltd. (K123354)

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 is circular and features the department's name around the perimeter. In the center is a stylized symbol of three human profiles facing right, with flowing lines representing the concept of health and well-being.

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

March 23, 2015

Actegy, Ltd % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, DC 20004

Re: K143207

> Trade/Device Name: Revitive IX (OTC) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: November 7, 2014 Received: November 7, 2014

Dear Dr. 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

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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 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.

# Felipe Aquel -S

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

Enclosure

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510(k) Number (if known)

K143207

Device Name

Revitive IX (OTC)

Indications for Use (Describe)

- . To temporarily increase local blood circulation in healthy leq muscles.
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- . For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (leqs) due to strain from exercise or normal household duties.

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

□ Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

## Actegy's Revitive IX (OTC)

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

Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK

| Phone: | [phone] |
|------------|---------------------|
| Facsimile: | [phone] |

| Contact Person: | Angela Glover |
|-----------------|----------------|
| Date Prepared: | March 18, 2015 |

### Name of Device and Name/Address of Sponsor

Revitive IX (OTC) - Model: RIX

- Actegy Ltd. Reflex Cain Road Bracknell Berkshire, RG12 1HL UK
#### Common or Usual Name

Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device

#### Classification Name

Powered muscle stimulator for muscle conditioning, 21 C.F.R. § 890.5850, product code NGX/NUH

### Predicate Devices

OTC EMS Stimulator Model MT1001 Shenzhen Dongdixin Technology Co. Ltd (K133965) Prospera OTC TENS Electronic Pulse Massager - PL009 (K122744) Revitive IX (RX), Model: RIX Actegy Ltd. (K123354)

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## Device Description

The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.

Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.

The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.

### Intended Use / Indications for Use

The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.

Revitive IX (OTC) is indicated for:

- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

### Technological Characteristics

The Revitive IX (OTC) is a mid-frequency (20-53Hz) Electrical Muscle Stimulator providing pulsed symmetrical biphasic, rectangular and bipolar waveforms utilizing Conductive Footpads & Self Adhesive Cutaneous Electrodes and rocker feature. The device provides an output current of 10-14mA@500Ω r.m.s. and maximum output voltage of 32V@500Ω. Intensity is controlled via the user

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interface in 1-99 incremental steps. The duration of the treatment session can be set between 1 and 60 minutes.

#### Performance Data

Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted in accordance with the following standards:

| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 | Biological evaluation of medical devices. Tests for irritation and skin sensitization |
| BS EN 60601-1 | Medical electrical equipment. General requirements for basic safety and essential performance |
| BS EN 60601-1-2 | Medical electrical equipment - part 1-2: general requirements for safety - collateral standard: electromagnetic compatibility - requirements and tests |
| EN 60601-2-10 | Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
| BS EN 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. |

In all instances, the Revitive IX (OTC) functioned as intended and the results observed were as expected.

A Usability study was conducted to determine that the intended users can identify they are appropriate users of the device and to assess whether they can operate the device in a safe and effective manner based on their reading and following the directions for use contained in the device labeling. The Revitive IX (OTC) summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011). In summary, it was established that the Revitive IX (OTC) device, as labeled, is safe and effective in the hands of the intended population and therefore is suitable for Over-The- Counter use.

#### Substantial Equivalence

The Revitive IX (OTC) is as safe and effective as its predicate devices. The Revitive IX (OTC) has the same technological characteristics, and principles of operation and similar indications and intended uses, as its predicate devices. The differences in Indications between the Revitive IX (OTC) and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX (OTC) is as safe and effective as the predicate devices and is suitable for Over-The- Counter use. Thus, the Revitive IX (OTC) is substantially equivalent.

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# Actegy Ltd's

# REVITIVE IX (OTC)

# Substantial Equivalence Chart

| | | | OTC TENS Electronic Pulse | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Revitive IX (OTC) | OTC EMS Stimulator | Massager - PL009 | Revitive IX (Rx) |
| | Candidate | Primary Predicate | Secondary Predicate | Secondary Predicate |
| 510(k) Number | TBD | K133965 | K122744 | K123354 |
| Device Name, Model | REVITIVE IX (OTC), RIX | OTC EMS Stimulator, MT1001 | OTC TENS Electronic Pulse<br>Massager - PL009 | REVITIVE IX (RX), RIX |
| Product Code: | NGX/NUH | NGX | NUH/NGX | IPF |
| Intended Use | Intended for electrical stimulation of<br>the lower leg and other muscles for<br>various indications | Intended for electrical<br>stimulation of the lower leg for<br>various indications | Intended for electrical<br>stimulation of tired and sore<br>muscles | Intended for electrical<br>stimulation of the lower leg for<br>various indications |
| Indications for Use | To temporarily increase local blood<br>circulation in healthy leg muscles.<br>To stimulate healthy muscles in order<br>to improve and facilitate muscle<br>performance.<br>For temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist, back,<br>upper extremities (arms) and lower<br>extremities (legs) due to strain from<br>exercise or normal household duties. | The OTC EMS stimulator<br>MT1001 is intended to<br>stimulate healthy muscles of<br>the lower extremity in order to<br>temporarily increase local<br>blood circulation and to<br>stimulate healthy muscles in<br>order to improve and facilitate<br>muscle performance. | To be used for temporary relief<br>of pain associated with sore<br>and aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm) and<br>lower extremities (leg) due to<br>strain from exercise or normal<br>household activities. | 1. Relaxation of muscle<br>spasms:<br>2. Prevention or retardation of<br>disuse atrophy:<br>3. Increasing local blood<br>circulation:<br>4. Muscle re-education:<br>5. Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis;<br>and<br>6. Maintaining or increasing<br>range of motion. |
| Technological Characteristics | Mid Frequency (20-53Hz) Electrical<br>Muscle Stimulator providing pulsed<br>symmetrical biphasic, rectangular and<br>bipolar waveforms utilizing<br>Conductive Footpads & Self Adhesive<br>Cutaneous Electrodes and rocker<br>feature | Mid Frequency (10-36Hz)<br>Electrical Muscle Stimulator<br>providing pulsed symmetrical<br>biphasic, rectangular and<br>bipolar waveforms utilizing<br>Conductive Footpads & Self<br>Adhesive Cutaneous<br>Electrodes and rocker feature | Mid Frequency (1-63Hz)<br>Electrical Muscle Stimulator<br>providing pulsed monophasic,<br>rectangular waveforms utilizing<br>Self Adhesive Cutaneous<br>Electrodes | Mid Frequency (20-53Hz)<br>Electrical Muscle Stimulator<br>providing pulsed symmetrical<br>biphasic, rectangular and<br>bipolar waveforms utilizing<br>Conductive Footpads & Self<br>Adhesive Cutaneous<br>Electrodes and rocker feature |
| Accessories | Self Adhesive Cutaneous Electrodes | Self Adhesive Cutaneous<br>Electrodes | Self Adhesive Cutaneous<br>Electrodes | Self Adhesive Cutaneous<br>Electrodes |
| | Revitive IX (OTC) | OTC EMS Stimulator | OTC TENS Electronic Pulse<br>Massager - PL009 | Revitive IX (Rx) |
| Manufacturer | Actegy Ltd | Shenzhen Dongdixin<br>Technology Co. Ltd. | Prospera Corporation | Actegy Ltd |
| Dimensions (mm) [W x H x D] | Ø360mm x 75mm | 427.3 x 416.5 x 103.7mm | 2.24 x 7.80 x 0.91in | Ø360mm x 75mm |
| Weight | 1725g (not including PSU) | 1910g (device only, excluding<br>batteries) | 8.21 oz | 1725g (not including PSU) |
| Power Source(s) | Power adaptor<br>Input: 100-240V, 50/60Hz, 0.18A.<br>Output: 5.0Vdc, 1.0A | Power adaptor<br>Input: 100-240V, 50/60Hz,<br>Output: 6.0Vdc, 300mA<br>Or 6.0Vdc, 4xC batteries | 6V battery | Power adaptor<br>Input: 100-240V, 50/60Hz,<br>0.18A.<br>Output: 5.0Vdc, 1.0A |
| Safety Features | Automatic Shut off, Override Control | Automatic Shut off, Override<br>Control | Automatic Shut off, Override<br>Control | Automatic Shut off, Override<br>Control |
| Biocompatibility | Yes | Unknown | Yes | Yes |
| Number of Output Modes | 1 | 1 | 3 | 1 |
| Number of Output Channels | 2 (1 for Foot, 1 for body pads) | 3 (2 for foot, 1 for body) | 2 | 2 (1 for Foot, 1 for body pads) |
| Software/Firmware/<br>Microprocessor Control? | Yes | Yes | Yes | Yes |
| Voltage/Current Level? | Yes: 1-99 intensity indicator | Yes: 1-99 intensity indicator | Yes: 1-10 intensity dial | Yes: 1-99 intensity indicator |
| Timer Range (minutes) | 1 to 60 minutes | 1 - 99 minutes | 15 minutes | 1 to 60 minutes |
| Compliance with Voluntary<br>Standards? | MDD (93/42EEC), EN 60601-1,<br>EN60601-1-2, EN 60601-1-11,<br>EN60601-2-10 | Unknown | IEC60601-1:<br>IEC60601-1-2;<br>IEC60601-2-10 | MDD (93/42EEC), EN 60601-1,<br>EN60601-1-2, EN 60601-1-11,<br>EN60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Unknown | Yes | Yes |
| Housing Materials and<br>Construction | Casing/body ABS, footpads NBR | Unknown | Enclosure ABS | Casing/body ABS, footpads<br>NBR |
| Sterilization | Not provided sterile | Not provided sterile | Not provided sterile | Not provided sterile |
| Biocompatibility | Yes | Unknown | Yes | Yes |

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