[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
[CITE: 21CFR882.5890]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 882 — NEUROLOGICAL DEVICES
Subpart F–Neurological Therapeutic Devices
Sec. 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 standard