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Activbody, Inc. recalls Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the
Recalled December 22, 2021 · FDA recall Z-0385-2022 · Activbody
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. · FDA Class II
Units
501 kits
Sold at
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. O.U.S.: Not provided
Description
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.
Product
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.
Manufacturer(s)
Activbody, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →