(59 days)
TENS: 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: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS Stimulation (OTC) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
The document only provides the following:
- Device Name: TENS and EMS Stimulation (OTC)
- 510(k) Number: K230174
- Indications for Use:
- TENS: 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: Stimulation of healthy muscles in order to improve or facilitate muscle performance.
- Type of Use: Over-The-Counter Use
Therefore, I cannot provide the requested table and details about the study because the necessary information is not present in the given FDA 510(k) clearance letter. This type of letter confirms regulatory clearance but typically does not include the detailed performance study results that were submitted to the FDA as part of the overall submission.
§ 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).