(125 days)
THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS:
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
POWERED MUSCLE STIMULATOR
The provided text is a 510(k) clearance letter from the FDA for a device named "MS-One (MS-1)," a powered muscle stimulator. It does not contain information about acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth, sample sizes, or expert adjudication as requested in your prompt.
The document only states the "Indications for Use" for which substantial equivalence was sought and granted. These are:
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Therefore, I cannot provide the requested table or answer the specific questions about the study, ground truth, sample sizes, or expert involvement because that information is not present in the provided text. This document is a regulatory approval letter, not a scientific study report.
§ 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).