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
97–120 of 548
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 Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234
Chattanooga Group, Inc.
Physical Medicine · 35d
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 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 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 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 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 Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
K841647
Intermedics, Inc.
Physical Medicine · 74d