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