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1.Relaxation of muscle spasms;

2.prevention or retardation of disuse atrophy;

3.increasing local blood circulation;

4.muscle re-education;

5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and

6. Maintaining or increasing range of motion.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called the "UTS Electrical Muscle Stimulation Device - PGS 4000". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance study report.

Therefore, I cannot provide the requested information in the form of a table or detailed answers because the input text does not contain these details.

Here's a breakdown of why the information is missing:

• Type of Document: This is an FDA clearance letter, which acknowledges substantial equivalence, rather than a detailed performance study report. It focuses on regulatory approval based on comparison to existing devices.
• Lack of Performance Data: The letter provides the "Indications For Use" (which one might loosely consider high-level "acceptance criteria" for what the device is intended to do), but it doesn't present specific, quantifiable performance metrics, study design, or results demonstrating that the device achieves those indications with a certain level of efficacy or safety.
• No Study Details: There is no mention of sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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