Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation 882.5870
1510(k)s in 12 months (25 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in GZF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 8 | 0 |
| Stimwave Technologies Inc | 0 | 6 |
| Bioness, Inc. | 4 | 0 |
| Bioventus, LLC | 3 | 0 |
| Boston Scientific Neuromodulation | 2 | 0 |
| Nalu Medical, Inc. | 1 | 1 |
| Neuspera Medical, Inc. | 2 | 0 |
| Advanced Neuromodulation Systems | 1 | 0 |
| Curonix | 1 | 0 |
| Micron Medical Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Nalu Medical, Inc. Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US
Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US
Components of the Nalu Spinal Cord Stimulation System. Open, Classified |
GZF | K183047 K183579 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, in Open, Classified |
GZF | K152178 K171366 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral Open, Classified |
GZF | K152178 K171366 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of periphera Open, Classified |
GZF | K152178 K171366 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intrac Open, Classified |
GZF | K152178 K171366 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral Open, Classified |
GZF | K152178 K171366 |
| Sep 2, 2020 | Stimwave Technologies Inc StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intra Open, Classified |
GZF | K152178 K171366 |
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