(90 days)
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.
This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:
- Device name and product codes
- Regulation numbers and regulatory class
- Indications for Use
- Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)
It does not include:
- Details on performance studies.
- Specific acceptance criteria used for performance verification.
- Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.
§ 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).