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§882.5870. Implanted peripheral nerve stimulator for pain relief.

21 C.F.R. § 882.5870

(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 implanted 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).
Notes, amendments, and revision history

Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 78 FR 18234, Mar. 26, 2013]

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 78 FR 18234, Mar. 26, 2013]