Stimulator, Muscle, Powered, For Muscle Conditioning
FDA adverse event reports and recall history for stimulator, muscle, powered, for muscle conditioning (product code NGX), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 100
- Deaths
- 0
- Injuries
- 80
- Malfunctions
- 19
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2013-11-07TerminatedNo Marketing Application
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Failure to submit a premarket submission and gain approval of a medical device.
- 2013-11-07TerminatedNo Marketing Application
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Failure to submit a premarket submission and gain approval of a medical device.
- TerminatedLabeling Change Control
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
Monitor stimulator, muscle, powered, for muscle conditioning automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.