Recall Z-0385-2022— Activbody, Inc.

Name: FDA recall Z-0385-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-30

Class II · Ongoing

Class II FDA medical device recall by Activbody, Inc., initiated 2021-11-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm: Activbody, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-11-30
Firm location: San Diego, CA, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.