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ManaMed
Manamed, Inc. · Model ManaEZ Wrist Universal Left · UDI-DI 00850998008126
10
510(k) clearances
48
Adverse events
1
Recalls
430
Facilities
Description
The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system makes it easier for the user to self apply the brace. Low profile, high quality lace design system Universal sizing
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.