Activ5 Smart Fitness Device Recalled for Inaccurate Force Measurement
Activbody is recalling the Activ5 smart fitness device due to manufacturing defects causing inaccurate force measurements, which may lead to incorrect treatment planning. The device was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with a manufacturing defect causing inaccurate force measurement. While no injuries have been reported, the defect poses a risk of incorrect treatment planning, particularly for rehabilitation users where measurement accuracy is critical. Per the rubric, a risk-of-harm product without reported injury is scored 3 (High).
Plain-English summary
The Activ5 is a smart strength training and rehabilitation device manufactured by Activbody, Inc. The company has issued a recall due to a manufacturing defect resulting in inaccurate force measurement.
The inaccurate force measurements may lead to incorrect treatment planning. This is particularly significant for users relying on the device for rehabilitation purposes, where precise measurements are critical for appropriate therapy.
The recalled devices were distributed nationwide, including all U.S. states and Puerto Rico. Consumers should discontinue use and contact Activbody, Inc. regarding replacement or refund options.
The FDA has classified this as a Class II recall. The recall was also prompted by the firm's failure to register and list the medical devices with the U.S. Food and Drug Administration.
The recalled product
- 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
- Activbody, Inc.
- Hazard
- inaccurate-force-measurement
- incorrect-treatment-planning
Distribution
Distributed in 43 states:
- 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
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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