Reported Dec 22, 2021 · Ongoing
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5,…
Activbody, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Activbody, Inc. · 4435 Eastgate Mall · San Diego, CA · 92121-1982
Is this the product you have?
- Box Labelactiv5
- TINY GYM IN YOUR POCKET activbody ModelActiv5
- User ManualACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device
- Lot codes and dates
- Activforce Kit NumberAB0000-AC5540
- Serial Numbers
1,713 of 1,713 codes
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
- Amount recalled
- 501 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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