LBBClass II

Dynamometer, Ac-powered

Orthopedic · 21 CFR 888.1240

MDR events0All time

Recalls2All time

Registered firms18Currently listed

510(k) clearances36All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

2 recall events for this product code

Activbody, Inc.
Open, ClassifiedUnknown
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5
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.
Z-0385-2022 · View FDA record ↗
Activbody, Inc.
Open, ClassifiedUnknown
activforce 2 package labeling: Model: Activ5-M R 201-200563
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.
Z-0386-2022 · View FDA record ↗

Registered firms

18 firms currently registered for this product code

510(k) clearances

36 clearances for this product code