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OraStretch® Press Device – Pediatric
Cranio Mandibular Rehab, Inc. · Model CR1005 · UDI-DI 00850056079037
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 Pediatric size is generally for patients under 10 years-old.
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.