(30 days)
TENS (mode 1-3)
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 (mode 4-6)
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 TENS and EMS units (SM9109A, SM9109B). This type of document does not typically contain acceptance criteria or detailed study results for the device's performance.
510(k) clearances are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness from scratch. The letter confirms that the device is substantially equivalent for the stated indications for use, meaning its performance is considered comparable to existing devices on the market.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. This information would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated test reports and clinical data summaries provided by the manufacturer to the FDA.
§ 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).