LogoFDA 510(k) Search
K Number
K210825
Device Name
Revitive Medic Coach (Model Number 5575AQ)
Manufacturer
Actegy, Ltd.
Date Cleared
2021-12-17

(273 days)

Product Code
NGX,GZJ,IPF,NUH,NYN
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Revitive Medic Coach (Model Number 5575AQ). It outlines the device's indications for use and regulatory classifications, but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the input text.

§ 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).