Stimwave Technologies Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2930-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Produc | July 15, 2020 |
| Z-2929-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for per | July 15, 2020 |
| Z-2932-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for per | July 15, 2020 |
| Z-2928-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Produ | July 15, 2020 |
| Z-2933-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Pr | July 15, 2020 |
| Z-2931-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for pe | July 15, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191466 | SandShark Injectable Anchor (SIA) System | November 7, 2019 |