21 CFR § 882.5880 Neurological Devices

§ 882.5880 Implanted spinal cord stimulator for pain relief.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.5870 Implanted peripheral nerve stimulator for pain relief.§ 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome. →