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OmniTour
ACCELERATED CARE PLUS CORP · Model OmniTourSoftware · UDI-DI 00858703006375
ION
Prescription
10
510(k) clearances
117
Adverse events (2 deaths)
2
Recalls
256
Facilities
Description
Therapy cycling feedback software
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-27 | Amtryke LLC | Product is being recalled due to complaints of cracked frames. |
| 2011-07-11 | North Coast Medical Inc | Potential for plastic D-ring to break during use and cause injury. |
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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.