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Konmed
Shenzhen Konmed Technology Co., Ltd. · Model KM-W-19 · UDI-DI 06970935830239
10
510(k) clearances
48
Adverse events
1
Recalls
428
Facilities
Description
It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable in order to make effective oppression, reduce swelling and convenient for use, it is designed with below feature: - Soft and convenient to wear - Different wearing style, such as: fix on your palm and wrist, fix on your palm and fingers - Extractable aluminum alloy is, for easy cleaning and adjustment - Detachable straps to meet the needs of different person
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.