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TM "Rehabilitimed" TUTOR-6K-VU UNI Right
REABILITIMED TOV · Model TUTOR-6K-VU UNI Right · UDI-DI 04823097708422
10
510(k) clearances
48
Adverse events
1
Recalls
427
Facilities
Description
It is a wrist and thumb joint fixator, black. Made of elastic, breathable material, effectively maintains the temperature balance of the skin. Reinforced with two metal profiled tires that completely limit movement in the thumb and wrist joints. Tightening straps with textile fasteners on the forearm and thumb fix in the optimal position and support the tendons of the flexors and extensors of the hand.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-18 | North Coast Medical Inc | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
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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.