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
169–192 of 548
Cleared Aug 29, 1997
MSI MAGNA-STYM
K972055
Microvas Systems, Inc.
Physical Medicine · 88d
Cleared Aug 14, 1997
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542
Rehabilicare, Inc.
Physical Medicine · 108d
Cleared Apr 15, 1997
EGS4000
K955666
S&P Electrical Industries, Inc.
Physical Medicine · 489d
Cleared Mar 17, 1997
NEURO-TRAIN II (2)
K970155
Sterne Equipment Co., Ltd.
Physical Medicine · 60d
Cleared Feb 03, 1997
SYS STIM 226
K964028
Mettler Electronics Corp.
Physical Medicine · 119d
Cleared Jan 24, 1997
AXIOM INF
K964423
Axiom Manufacturing
Physical Medicine · 112d
Cleared Dec 04, 1996
XH-1 NEUROMUSCULAR STIMULATOR
K950550
California Medical Research Institute
Physical Medicine · 672d
Cleared Sep 23, 1996
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462
Smith and Nephew Donjoy, Inc.
Physical Medicine · 90d
Cleared Sep 06, 1996
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
K960457
Med Labs, Inc.
Physical Medicine · 220d
Cleared May 23, 1996
HANDMASTER NMS1
K952273
Neuromusclar Electrical Stimulation Systems, Ltd.
Physical Medicine · 374d
Cleared May 22, 1996
STIM-8
K955736
Bmr , Ltd.
Physical Medicine · 156d
Cleared May 21, 1996
VST-10, VST-10/2
K960433
Vcare Intl., Inc.
Physical Medicine · 111d
Cleared May 17, 1996
AXIOM-HVG
K955146
Axiom Manufacturing
Physical Medicine · 186d
Cleared Mar 27, 1996
ULTRA III
K960096
Excel Tech. , Ltd.
Physical Medicine · 76d
Cleared Mar 27, 1996
ULTRA IV
K960489
Excel Tech. , Ltd.
Physical Medicine · 54d
Cleared Feb 28, 1996
GALVA-5-M
K954411
Zimmer Elektromedizin GmbH
Physical Medicine · 160d
Cleared Oct 27, 1995
FORTE ES-400
K953615
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared Aug 14, 1995
BX-400S
K942195
Bloomex International, Inc.
Physical Medicine · 489d
Cleared Aug 14, 1995
BX-200 SC
K943185
Bloomex International, Inc.
Physical Medicine · 489d
Cleared Aug 14, 1995
CHAL-2500
K946186
Hogan & Hartson
Physical Medicine · 237d
Cleared Jun 22, 1995
DYNATRON 250
K944935
Dynatronics Corp.
Physical Medicine · 259d
Cleared May 19, 1994
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared Jan 07, 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916
Biomedical Life Systems, Inc.
Physical Medicine · 205d
Cleared Nov 06, 1992
IF-II (TM), MODEL 7200
K923914
Medical Devices, Inc.
Physical Medicine · 98d