21 CFR 882.5880 — Stimulator, Spinal-Cord, Implanted (Pain Relief)
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5880
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 2 | 139 | Implant |
| LHG | Electrode, Spinal Epidural | 2 | 1 | Implant |
