510(k) K171366 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
| Applicant | Stimwave Technologies Inc., Dba Stimq, LLC, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 4, 2017 |
| Received | May 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.