Revitive Medic Plus, Revitive Advanced 2

K190924 · Actegy , Ltd. · NGX · Jul 5, 2019 · Physical Medicine

Device Facts

• Record ID: K190924
• Device Name: Revitive Medic Plus, Revitive Advanced 2
• Applicant: Actegy , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Jul 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NMES: - 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 - For relaxation of muscle spasm, - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education, - Maintaining or increasing range of motion, and - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - 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 activities

Device Story

Revitive Medic Plus and Revitive Advanced 2 are powered muscle stimulators providing NMES and TENS therapy. Devices deliver electrical stimulation via electrodes to stimulate muscles or nerves. Intended for OTC use by patients for pain relief, circulation improvement, and muscle conditioning. Operation involves applying stimulation to target areas (legs, back, etc.) to manage chronic pain, reduce spasms, or prevent atrophy. Output affects muscle contraction or nerve signaling to achieve therapeutic goals. Benefits include pain management, improved circulation, and muscle maintenance without clinical supervision.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator (Class II). Provides NMES and TENS modalities. Device utilizes electrical stimulation for muscle/nerve activation. Form factor designed for OTC use. Connectivity and specific material standards not detailed in provided text.

Indications for Use

Indicated for individuals requiring NMES for temporary increase of local blood circulation, muscle performance improvement, relief of sore/aching muscle pain (shoulder, waist, back, extremities), muscle spasm relaxation, prevention of disuse atrophy, muscle re-education, range of motion maintenance, and post-surgical calf stimulation to prevent venous thrombosis. Also indicated for TENS for symptomatic relief of chronic intractable pain, arthritis-associated pain, and sore/aching muscle pain due to exercise or household activities.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 5, 2019

Actegy, Ltd. % Carmelina G. Allis Attorney The Allis Law Firm, PLLC 2437 Bay Area Blvd. #30 Houston, Texas 77058

Re: K190924

Trade/Device Name: Revitive Medic Plus, Revitive Advanced 2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, GZJ, IPF, NYN Dated: April 9, 2019 Received: April 9, 2019

Dear Carmelina Allis:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director, Acute Injury Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190924

Device Name Revitive Medic Plus Revitive Advanced 2

Indications for Use (Describe)

NMES:

- 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
- For relaxation of muscle spasm,
- Increase of blood flow circulation,
- Prevention or retardation of disuse atrophy,
- Muscle re-education,
- Maintaining or increasing range of motion, and
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

## TENS:

- For symptomatic relief and management of chronic intractable pain
- Relief of pain associated with arthritis

- 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 activities

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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