Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Regulation 882.5890
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NHI
| Company | 510(k)s | Recalls |
|---|---|---|
| Spr Therapeutics, Inc. | 6 | 0 |
| Dyansys, Inc. | 4 | 0 |
| Vertis Neuroscience, Inc. | 2 | 0 |
| Biowave Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2023 | K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System Spr Therapeutics, Inc. | NHI |
| Sep 13, 2022 | K221425 | Primary Relief Dyansys, Inc. | NHI |
| May 12, 2022 | K220397 | ANSiStim-PP Dyansys, Inc. | NHI |
| Jan 31, 2022 | K213188 | Primary Relief Dyansys, Inc. | NHI |
| Dec 20, 2021 | K212859 | First Relief Dyansys, Inc. | NHI |
| Oct 13, 2021 | K211801 | SPRINT PNS System Spr Therapeutics, Inc. | NHI |
| Jan 22, 2021 | K202660 | SPRINT PNS System Spr Therapeutics, Inc. | NHI |
| Jul 31, 2018 | K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Spr Therapeutics, Inc. | NHI |
| Jun 26, 2017 | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit Spr Therapeutics, LLC | NHI |
| Jul 23, 2016 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Spr Therapeutics, LLC | NHI |
| Aug 15, 2006 | K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM Biowave Corporation | NHI |
| Sep 11, 2002 | K022241 | VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX Vertis Neuroscience, Inc. | NHI |
| Dec 21, 2001 | K011702 | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX Vertis Neuroscience, Inc. | NHI |
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