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 Empi.

548
Total
548
Cleared
157d
Avg days
1976
Since
548 devices
73–96 of 548
Cleared Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749
Biomedical Life Systems, Inc.
Physical Medicine · 199d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808
Rich-Mar Corp.
Physical Medicine · 165d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Apr 03, 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448
Radionics, Inc.
Physical Medicine · 57d
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 Oct 27, 1995
FORTE ES-400
K953615
Chattanooga Group, Inc.
Physical Medicine · 85d
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
Cleared May 22, 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833
Rich-Mar Corp.
Physical Medicine · 87d
Cleared May 20, 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436
Medtronic Vascular
Physical Medicine · 107d
Cleared Dec 18, 1991
RICH-MAR IFV 1000
K914539
Rich-Mar Corp.
Physical Medicine · 68d
Cleared Oct 22, 1990
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599
Chattanooga Group, Inc.
Physical Medicine · 132d
Cleared Jun 26, 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779
Rich-Mar Corp.
Physical Medicine · 70d
Cleared Mar 26, 1990
ISOTRON 220
K900823
Excel Tech. , Ltd.
Physical Medicine · 34d
Cleared Mar 07, 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413
Chattanooga Group, Inc.
Physical Medicine · 43d
Cleared Feb 20, 1990
EMS 8100
K895301
Henley Intl.
Physical Medicine · 179d
Cleared Feb 20, 1990
MULTISTIM PLUS
K895983
Excel Tech. , Ltd.
Physical Medicine · 148d
Cleared Feb 20, 1990
EXCEL STIM
K896836
Excel Tech. , Ltd.
Physical Medicine · 99d
Cleared Dec 14, 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994
Rich-Mar Corp.
Physical Medicine · 192d