(90 days)
THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS : - Relaxation of muscle spasms 1. - 2. Prevention or retardation of disuse atrophy - Increasing local blood circulation 3 . - Muscle re-education 4 . - Immediate post-surgical stimulation of calf muscles to 5. prevent venous thrombosis - Maintaining or increasing range of motion 6.
MEDS-3 NEUROMUSCULAR STIMULATOR
The provided text is a 510(k) clearance letter from the FDA for the MEDS-3 Neuromuscular Stimulator. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device was compared against existing, similar devices already cleared for market, rather than undergoing a de novo study with explicit acceptance criteria.
§ 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).