(88 days)
The proposed device will have the following indications: prevention and retardation of muscle disuse atrophy, increase local blood flow, increase range of motion, prevent venous thrombosis with immediate postsurgical stimulation of calf muscles; relaxation of muscle spasms.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the MSI Magna-Stym device. It states that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the document does not contain any information about:
- Acceptance criteria table or reported device performance metrics.
- The study design, sample sizes, data provenance, number or qualifications of experts, or ground truth establishment for either test or training sets.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
Therefore, I cannot provide the requested information based on the given text. The document is solely a regulatory letter of approval, not a technical 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).