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The indications for use are:

1. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
2. Relaxation of muscle spasm (Interferential Mode);
3. Prevention or retardation of disuse atrophy (Interferential Mode);
4. Increasing local blood flow (Interferential Mode);
5. Muscle re-education (Interferential Mode);
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (Interferential Mode); and
7. Maintaining or increasing range of motion (Interferential Mode).

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I am sorry, but based on the text provided, I cannot answer your question. The document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Vectorsurge 5 Model VS 470." It discusses regulatory classifications, general controls, and indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case comparative effectiveness study or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.

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