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 Empi.
548
Total
548
Cleared
157d
Avg days
1976
Since
548 devices
Cleared
Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
Rich-Mar Corp.
Physical Medicine
66d
Cleared
Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Rich-Mar Corp.
Physical Medicine
66d
Cleared
Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
Biomedical Life Systems, Inc.
Physical Medicine
199d
Cleared
Jun 06, 2001
SMITH & NEPHEW RESTIM
Smith & Nephew, Inc.
Physical Medicine
197d
Cleared
Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
Rich-Mar Corp.
Physical Medicine
165d
Cleared
Nov 06, 1998
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
Chattanooga Group, Inc.
Physical Medicine
87d
Cleared
Apr 03, 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
Radionics, Inc.
Physical Medicine
57d
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
Oct 27, 1995
FORTE ES-400
Chattanooga Group, Inc.
Physical Medicine
85d
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
Cleared
May 22, 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
Rich-Mar Corp.
Physical Medicine
87d
Cleared
May 20, 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
Medtronic Vascular
Physical Medicine
107d
Cleared
Dec 18, 1991
RICH-MAR IFV 1000
Rich-Mar Corp.
Physical Medicine
68d
Cleared
Oct 22, 1990
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
Chattanooga Group, Inc.
Physical Medicine
132d
Cleared
Jun 26, 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
Rich-Mar Corp.
Physical Medicine
70d
Cleared
Mar 26, 1990
ISOTRON 220
Excel Tech. , Ltd.
Physical Medicine
34d
Cleared
Mar 07, 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
Chattanooga Group, Inc.
Physical Medicine
43d
Cleared
Feb 20, 1990
EMS 8100
Henley Intl.
Physical Medicine
179d
Cleared
Feb 20, 1990
MULTISTIM PLUS
Excel Tech. , Ltd.
Physical Medicine
148d
Cleared
Feb 20, 1990
EXCEL STIM
Excel Tech. , Ltd.
Physical Medicine
99d
Cleared
Dec 14, 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
Rich-Mar Corp.
Physical Medicine
192d