21 CFR § 882.5880 - Implanted spinal cord stimulator for pain relief.

---
identifier: "/us/cfr/t21/s882.5880"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.5880 - Implanted spinal cord stimulator for pain relief."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.5880"
section_name: "Implanted spinal cord stimulator for pain relief."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 882.5880 Implanted spinal cord stimulator for pain relief.

(a) *Identification.* An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

(b) *Classification.* Class II (performance standards).