(282 days)
INDICATIONS: Transcutaneous Electrical Nerve Stimulator (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Not Found
The provided text is a 510(k) clearance letter from the FDA for two TENS devices, "Multi-Stim TENS, AP-101081T" and "Acu-Stim TENS, AP-101082T."
Crucially, this document does not contain any information about acceptance criteria or a study proving device performance.
A 510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not on proving new efficacy or meeting specific performance criteria through new clinical trials as would be required for a PMA (Premarket Approval) application. The letter explicitly states: "We have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976..."
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a performance study.
§ 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).