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TheraBite ActiveBand Kit
Atos Medical AB · Model 8260 · UDI-DI 07331791004827
10
510(k) clearances
117
Adverse events (2 deaths)
2
Recalls
255
Facilities
Description
The TheraBite ActiveBand is an elastic silicone band used together with the TheraBite Jaw Mobilizer to increase and/or maintain muscle strength and endurance of the muscles of mastication (chewing muscles). The TheraBite ActiveBand is intended for single-patient use only.
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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