IPF · Class II · 21 CFR 890.5850

FDA Product Code IPF: Stimulator, Muscle, Powered

FDA product code IPF covers powered muscle stimulators used in physical medicine and rehabilitation.

These devices deliver low-level electrical impulses to motor nerves or muscle tissue to elicit muscle contractions, preventing atrophy, re-educating paralyzed muscles, and reducing muscle spasm. They are used in the rehabilitation of neurological and orthopedic conditions.

IPF devices are Class II medical devices, regulated under 21 CFR 890.5850 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include Rich-Mar Corp., Chattanooga Group, Inc. and Mettler Electronics Corp..

548
Total
548
Cleared
157d
Avg days
1976
Since
548 devices
97–120 of 548
Cleared Jun 01, 2011
H-WAVE
K103738
Electronic Waveform Laboratory, Inc.
Physical Medicine · 161d
Cleared Mar 05, 2010
EMPI CONTINUUM
K093324
Empi
Physical Medicine · 133d
Cleared Feb 12, 2010
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003
K093138
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 130d
Cleared Jan 29, 2010
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
K100117
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 14d
Cleared Dec 30, 2009
KNEEHAB XP CONTROLLER, MODEL 411
K092791
Bio-Medical Research, Ltd.
Physical Medicine · 110d
Cleared Nov 30, 2009
MAXEMS, MODELS 1000 AND 2000
K091248
Bio Protech, Inc.
Physical Medicine · 216d
Cleared Jul 24, 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105
Bio-Medical Research, Ltd.
Physical Medicine · 277d
Cleared Jan 26, 2007
VECTRA GENISYS VMS FR
K062354
Encore Medical, L.P.
Physical Medicine · 165d
Cleared Dec 29, 2005
MYOTRAC INFINITI
K053266
Thought Technology , Ltd.
Physical Medicine · 36d
Cleared Dec 12, 2005
EASYSTIM NMS-28
K050921
Easy Med Instrument Co., Ltd.
Physical Medicine · 243d
Cleared Aug 11, 2005
AXIOM NVP8500
K051135
Axiom Worldwide, Inc.
Physical Medicine · 100d
Cleared Jul 28, 2005
AXIOM EPS8000
K050687
Axiom Worldwide, Inc.
Physical Medicine · 133d
Cleared Jun 17, 2005
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
K050847
Theratech, Inc.
Physical Medicine · 74d
Cleared May 23, 2005
FT2000 SEQUENCER FOR MUSCLE STIMULATOR
K050595
Midwest Development
Physical Medicine · 76d
Cleared Apr 13, 2005
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
K050046
Compex Technologies, Inc.
Physical Medicine · 93d
Cleared Mar 04, 2005
NEUROTECH KNEEHAB
K024258
Bio-Medical Research, Ltd.
Physical Medicine · 802d
Cleared Feb 09, 2005
DIAMOND MEDISTIM
K041390
Diamond Systems USA, Inc.
Physical Medicine · 260d
Cleared Jan 27, 2005
BIOMOVE 3000
K042650
Curatronic, Ltd.
Physical Medicine · 121d
Cleared Jan 21, 2005
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920
Empi
Physical Medicine · 189d
Cleared Dec 01, 2004
SMARTWAVE MS 2000
K041063
Newwave Medical, LLC
Physical Medicine · 222d
Cleared Nov 18, 2004
PMD-2000 INTERFERENTIAL STIMULATOR
K042881
Phoenix Medical Devices, LLC
Physical Medicine · 30d
Cleared Jun 30, 2004
BMLS03-3
K033174
Biomedical Life Systems, Inc.
Physical Medicine · 273d
Cleared Jun 08, 2004
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
K041146
Control Solutions, Inc.
Physical Medicine · 36d
Cleared Mar 23, 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306
Biomedical Life Systems, Inc.
Physical Medicine · 43d