SPRINT PNS System
Device Facts
| Record ID | K240974 |
|---|---|
| Device Name | SPRINT PNS System |
| Applicant | Spr Therapeutics, Inc. |
| Product Code | GZF · Neurology |
| Decision Date | Apr 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5870 |
| Device Class | Class 2 |
Regulatory Classification
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.
