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Panels › Physical Medicine › Product code IPF · Class 2

Stimulator, Muscle, Powered

Regulation 890.5850

3510(k)s in 12 months (548 all time)
0recalls in 12 months (7 all time)
3recalls that name a 510(k)
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Top companies in IPF

Company510(k)sRecalls
Rich-Mar Corp.170
Bloomex International, Inc.140
Chattanooga Group140
Mettler Electronics Corp.130
Maximum Performance Technologies, Mpts, Inc.110
Firstkind Limited100
Empi80
Rs Medical80
Bio-Medical Research Corp.70
Biomedical Life Systems, Inc.70
DateFirm and productCodeLinked 510(k)
Dec 7, 2023Liberty Medical Solutions, LLC
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Open, Classified		 IPFK093138
Jun 26, 2014Zynex Medical, Inc.
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
Terminated		 IPFK991241
Mar 1, 2012Ion Genius, Inc.
Arasys Product Usage: Muscle stimulation
Terminated		 IPFNone listed
Mar 1, 2012Ion Genius, Inc.
Ion Magnum Product Usage: Muscle stimulation
Terminated		 IPFNone listed
Mar 1, 2012Ion Genius, Inc.
Perfector Product Usage: Muscle stimulation
Terminated		 IPFNone listed
Jul 25, 2011eSwallow USA LLC
eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.
Terminated		 IPFNone listed
Nov 8, 2010International Rehabilitative Sciences, Inc.
The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, inst
Terminated		 IPFK032652

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