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