Search Results

• 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms)
• 2. Temporary relaxation of muscle spasm, (all waveforms except Microcurrent)
• 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent)
• 4. Increase of blood flow in the treatment area(all waveforms except Microcurrent)
• 5. Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent)
• 6. Muscle re-education, (all waveforms except Microcurrent)
• 7. Maintaining or increasing range of motion, (all waveforms except Microcurrent)

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for several medical devices, including the Sys*Stim® ME294. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510 (k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976... "

This means the FDA found the device "substantially equivalent" to predicate devices already on the market, rather than requiring a new study with acceptance criteria. The document focuses on regulatory compliance and the legal right to market the device, not on clinical performance metrics or studies.

Therefore, requested information, such as acceptance criteria tables, sample sizes, expert qualifications, study methodologies, and specific performance outcomes, cannot be extracted from the provided text.

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