Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0385-2022 — 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.

U.S. FDA — Device Enforcement · United States · 2021-11-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0385-2022
Date of alert
2021-11-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Activbody, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.