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Therapy Disc, Reduced Warranty
NALU MEDICAL, INC. · Model 34001-002 · UDI-DI 00812537035802
10
510(k) clearances
4,507
Adverse events (16 deaths)
7
Recalls
27
Facilities
Description
The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to the Nalu Implantable Pulse Generator. The Therapy Disc is positioned externally over the implant using an adhesive retention clip or textile belt and may be controlled using integrated buttons or via the Nalu Remote Control Application.
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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