(77 days)
Relaxation of muscle spasm.
Prevention of retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the MS300 and MS400 devices and does not contain information about acceptance criteria or a study proving that the devices meet them.
The document states that the FDA has determined the devices are substantially equivalent to devices marketed prior to May 28, 1976. This means the manufacturer did not have to submit new clinical study data to demonstrate safety and effectiveness if they could show substantial equivalence to an existing predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and the study details as it is not present in the provided 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).