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TM "Rehabilitimed" K-1TM S Comfort

REABILITIMED TOV · Model K-1TM S Comfort · UDI-DI 04823097721476

ITM
5
510(k) clearances
7
Adverse events
0
Recalls
39
Facilities

Description

The orthopedic device is graphite in color, has a dense structure, is an elastic circular knee joint orthosis made of aeroprene (aeroprene is a soft, breathable, highly elastic neoprene that has additional perforation holes on the entire surface that improve air and moisture exchange) with an insert made of a special mesh fabric under the knee, equipped with a relief limiting silicone ring around the hole for the patella, reinforced with two flexible spring stiffening ribs on the side surfaces and additional fixing straps.

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Data 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.