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[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