FDA
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.
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.
On 11/19/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers and followed up with a hardcopy letter on 11/30/2021 via US Postal Service, to inform them that the firm failed to register with the U.S. Food and Drug Administration and therefore must be recalled from the market, and the risk of using the affected products can result in Inaccurate force measurements may result from using these devices. If inaccurate measurements are used to judge rehabilitation progress, the most immediate consequence is an increased risk of re-injury to the patient.
Customers are instructed to:
1. Cease all use of these devices immediately. Use alternative methods and tools, such
as manual muscle testing to measure force and/or a goniometer to measure range of
motion.
2. Fill out the RECALL RETURN RESPONSE form.
3. Return the RECALL RETURN RESPONSE form and all devices in their possession to
the Recalling Firm using the included pre-paid envelope. Customers only need to return the handheld dynamometer unit. Do not return the case, packaging or any accessories.
For questions, contact support team via support@activbody.com