(87 days)
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
Not Found
I am sorry but the provided document is a 510(k) summary for a powered muscle stimulator (Revitive Medic Plus, Revitive Advanced 2) that specifies its indications for use and classification. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.
Therefore, I cannot provide the requested information based on this document.
§ 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).