CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART F—Neurological Therapeutic Devices (§882.5030 to §882.5975) > 882.5870—Implanted peripheral nerve stimulator for pain relief.

882.5870—Implanted peripheral nerve stimulator for pain relief.

(a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
(b) Classification. Class II (performance standards).