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Wearable Antenna Assembly/StimQ Wearable Antenna Gear
STIMWAVE TECHNOLOGIES INCORPORATED · Model PDBT-915-2K · UDI-DI 00818225020822
2
510(k) clearances
4,507
Adverse events (16 deaths)
7
Recalls
28
Facilities
Description
Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-03 | Nalu Medical, Inc. | Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the The |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
| 2020-07-15 | Stimwave Technologies Inc | The product contains a non-functional component not referenced in product labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.