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OraStretch® Press Device – Anterior
Cranio Mandibular Rehab, Inc. · Model CR1003 · UDI-DI 00850056079020
10
510(k) clearances
117
Adverse events (2 deaths)
2
Recalls
255
Facilities
Description
The OraStretch press system is indicated for individuals with, or at risk of trismus (limited oral opening) or jaw dysfunction. The appliance may also be used for physical therapy or rehabilitation of the mouth, jaw, or other orofacial tissues. The device is for single-patient use only. The Anterior size has a mouthpiece that only contacts the anterior teeth.
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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