(273 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or adaptive algorithms. The device description is also not available, which would be a key place to find such information.
Yes
The device is described as an adjunctive treatment for various conditions, including pain relief, improved circulation, muscle re-education, and prevention of disuse atrophy, all of which fall under the scope of therapeutic rather than diagnostic or other uses.
No
The provided text details the intended therapeutic uses of the device (e.g., pain relief, muscle stimulation, blood circulation improvement) using NMES and TENS, but it does not mention any diagnostic functions or capabilities.
No
The intended use clearly describes the application of Electrical Muscle Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS), which are physical modalities requiring hardware to deliver electrical impulses. The description of the device itself is missing, but the intended use strongly indicates a hardware component is necessary for the described functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided text describes the device's intended use as delivering Electrical Muscle Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). These are therapeutic modalities applied externally to the body to stimulate muscles and nerves for various purposes like pain relief, muscle strengthening, and improving circulation.
- Lack of In Vitro Testing: There is no mention of the device being used to analyze samples taken from the body. Its function is to apply electrical stimulation to the body.
Therefore, based on the intended use and description provided, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:
· for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieves 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,
- · for increase of blood flow circulation.
- · for prevention or retardation of disuse atrophy,
- · for muscle re-education,
- · for maintaining or increasing range of motion, and
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- · symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
· 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.
Product codes
NGX, NUH, IPF, NYN, GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs/ankles/feet, lower extremities, shoulder, waist, back, upper extremities (arms), calf muscles, knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 17, 2021
Actegy, Ltd. % Carmelina Allis Attornev The Allis Law Firm, PLLC 2532 North Fourth Street, #620 Flagstaff, Arizona 86004
Re: K210825
Trade/Device Name: Revitive Medic Coach (Model Number 5575AQ) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, IPF, NYN, GZJ Dated: November 12, 2021 Received: November 15, 2021
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices 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
2
Indications for Use
510(k) Number (if known) K210825
Device Name
Revitive Medic Coach (Model Number 5575AQ)
Indications for Use (Describe)
(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:
· for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieves 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,
- · for increase of blood flow circulation.
- · for prevention or retardation of disuse atrophy,
- · for muscle re-education,
- · for maintaining or increasing range of motion, and
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- · symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
· 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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