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., Mettler Electronics Corp. and Chattanooga Group, Inc..

548
Total
548
Cleared
157d
Avg days
1976
Since
548 devices
193–216 of 548
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 Dec 09, 1991
EMS300, EMS400, EMS8000
K912642
Skylark Device Co., Ltd.
Physical Medicine · 178d
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 Apr 16, 1990
SIEMENS STEREODYNATOR 828
K881431
Elmed, Inc.
Physical Medicine · 741d
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 19, 1989
SYS*STIM 206A
K893878
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 19, 1989
SYS*STIM 207A
K893879
Mettler Electronics Corp.
Physical Medicine · 207d
Cleared Dec 14, 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994
Rich-Mar Corp.
Physical Medicine · 192d
Cleared Nov 06, 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651
Biomedical Life Systems, Inc.
Physical Medicine · 364d
Cleared Mar 23, 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147
Rich-Mar Corp.
Physical Medicine · 69d
Cleared May 02, 1988
ENDOMED CV405
K880699
Henley Intl.
Physical Medicine · 70d
Cleared Apr 21, 1988
RICH-MAR G1000 EMS
K880948
Rich-Mar Corp.
Physical Medicine · 45d
Cleared Apr 08, 1988
INTELECT MODEL 120
K880235
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Mar 28, 1988
GV 11 (TM), MODEL 9700
K881082
Medical Devices, Inc.
Physical Medicine · 14d
Cleared Mar 10, 1988
SIEMENS NEUROTON 826 AND 827
K875238
Elmed, Inc.
Physical Medicine · 79d
Cleared Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234
Chattanooga Group, Inc.
Physical Medicine · 35d
Cleared Jan 22, 1988
MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
K871421
Futuremed Div. of Future Impex Corp.
Physical Medicine · 288d