§882.5870. Implanted peripheral nerve stimulator for pain relief.
21 C.F.R. § 882.5870
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.
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]