21 CFR 882.5870 — Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 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 Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 2 | 25 | Implant |
