Company ยท US
Stimwave Technologies Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2019. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2019 | K191466 | SandShark Injectable Anchor (SIA) System Stimwave Technologies, Inc. | GZB |
| Mar 29, 2019 | K182720 | Freedom Spinal Cord Stimulator (SCS) System Stimwave Technologies Incorporated | GZB |
| Sep 19, 2018 | K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit Stimwave Technologies Incorporated | GZB |
| Nov 3, 2017 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated | GZB |
| May 2, 2017 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated | GZB |
| Dec 16, 2016 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated | GZB |
| Aug 26, 2016 | K160600 | Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated | GZB |
| Jun 5, 2015 | K150517 | Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated | GZB |
| Oct 10, 2014 | K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM Stimwave Technologies Incorporated | GZB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |