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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 501
Distribution
Part of a larger recall action
This product is one of 2 recalled by Activbody, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Activbody, Inc.
See all →- HighActivforce 2 force measurement device recalled for inaccurate measurement
FDA (Devices) · 2021-12-22
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