Search Results

The OTC EMS stimulator MT1001 is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided text is a 510(k) summary for the Shenzhen Dongdixin Technology Co., Ltd. OTC EMS Stimulator MT1001. This document primarily focuses on FDA clearance for market entry based on substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the given text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement confirms that the device was cleared based on substantial equivalence, rather than a detailed performance study proving specific acceptance criteria.

Ask a specific question about this device