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Solaris Soundhead
Dynatronics Corporation · Model 9GSH10 · UDI-DI 10660584000208
IMI
Prescription
1
510(k) clearances
60
Adverse events
3
Recalls
25
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-02-28 | Chattanooga Corp Inc | Device may fail to administer therapy during use. |
| 2008-02-28 | Chattanooga Corp Inc | Device may fail to administer therapy during use. |
| 2005-01-05 | Sybaritic, Inc | Device is performing functions that are not cleared in the 510(k). |
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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.