C.F.R. » Title 21 » 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

21 C.F.R. § 882.5890

Transcutaneous electrical nerve stimulator for pain relief

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(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).