FDANovember 30, 2021device
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
What to do
FDA enforcement status: Ongoing
Brands named
activbody
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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