(139 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Tens & Ems Device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.
The content of the document is a regulatory approval notice, focusing on:
- The device being cleared (Tens & Ems Device).
- The regulation number and product codes.
- The indications for use (temporary pain relief for TENS, muscle stimulation for EMS).
- Its classification as an Over-The-Counter device.
- General FDA regulatory compliance information.
Therefore, I cannot provide the requested information from the given text. To answer your questions, details from the actual performance study report, which would have been part of the 510(k) submission, would be necessary.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).