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
217–240 of 548
Cleared Jan 22, 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736
Rich-Mar Corp.
Physical Medicine · 65d
Cleared Nov 17, 1987
RICH-MAR CONDUCTIVE GEL
K872036
Rich-Mar Corp.
Physical Medicine · 174d
Cleared Nov 03, 1987
INTELECT 775
K872655
Chattanooga Group, Inc.
Physical Medicine · 119d
Cleared Oct 01, 1987
MYOSTIM(TM), MODEL 6600
K872753
Medical Devices, Inc.
Physical Medicine · 80d
Cleared Sep 24, 1987
INTELECT MODEL 575
K872654
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Aug 18, 1987
DYNATRON 500
K870947
Dynatronics Corp.
Physical Medicine · 162d
Cleared Jun 16, 1987
DYNATRON 438
K870515
Henley Intl.
Physical Medicine · 131d
Cleared Dec 29, 1986
MYOPAC (TM), MODEL 9600
K864625
Medical Devices, Inc.
Physical Medicine · 34d
Cleared Dec 02, 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010
Empi
Physical Medicine · 48d
Cleared Jul 09, 1986
INTERSTIM 100 SYSTEM
K861136
Buckman Co., Inc.
Physical Medicine · 105d
Cleared Jun 10, 1986
RICH-MAR IF 200
K854485
Rich-Mar Corp.
Physical Medicine · 215d
Cleared Mar 28, 1986
HV-4
K853154
Robert Bosch Corp.
Physical Medicine · 242d
Cleared Mar 28, 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249
Mettler Electronics Corp.
Physical Medicine · 92d
Cleared Mar 28, 1986
SYS*STIM 206 (MODEL-ME 206)
K860107
Mettler Electronics Corp.
Physical Medicine · 74d
Cleared Feb 12, 1986
EMPI MODEL 720 NMS
K854774
Empi
Physical Medicine · 75d
Cleared Feb 12, 1986
EMPI MODEL 730 NMS
K854775
Empi
Physical Medicine · 75d
Cleared Nov 26, 1985
SYS*STIM 207 MODEL ME 207
K853750
Mettler Electronics Corp.
Physical Medicine · 78d
Cleared Jul 01, 1985
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046
3M Company
Physical Medicine · 109d
Cleared May 17, 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared Apr 08, 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013
Mettler Electronics Corp.
Physical Medicine · 96d
Cleared Mar 05, 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617
Excel Tech. , Ltd.
Physical Medicine · 98d
Cleared Feb 21, 1985
THE PROBE 100
K844466
Rich-Mar Corp.
Physical Medicine · 94d
Cleared Aug 21, 1984
INTERFERENZ 4
K842803
Robert Bosch Corp.
Physical Medicine · 35d
Cleared Aug 21, 1984
DIADYN 4
K842804
Robert Bosch Corp.
Physical Medicine · 35d