(204 days)
In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. In NMES Mode: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent deep venous thrombosis. Maintaining or increasing range of motion.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (IF8000) dated November 2, 1999. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use in Interferential Mode and NMES Mode.
However, it does not include details about:
- Acceptance criteria and reported device performance.
- The study that proves the device meets the acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
This document is a regulatory approval, not a technical report detailing the device's validation studies.
§ 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).