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
Nov 06, 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
Biomedical Life Systems, Inc.
Physical Medicine
364d
Cleared
Mar 23, 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
Rich-Mar Corp.
Physical Medicine
69d
Cleared
May 02, 1988
ENDOMED CV405
Henley Intl.
Physical Medicine
70d
Cleared
Apr 21, 1988
RICH-MAR G1000 EMS
Rich-Mar Corp.
Physical Medicine
45d
Cleared
Apr 08, 1988
INTELECT MODEL 120
Chattanooga Group, Inc.
Physical Medicine
79d
Cleared
Mar 28, 1988
GV 11 (TM), MODEL 9700
Medical Devices, Inc.
Physical Medicine
14d
Cleared
Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
Chattanooga Group, Inc.
Physical Medicine
35d
Cleared
Jan 22, 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
Rich-Mar Corp.
Physical Medicine
65d
Cleared
Nov 17, 1987
RICH-MAR CONDUCTIVE GEL
Rich-Mar Corp.
Physical Medicine
174d
Cleared
Nov 03, 1987
INTELECT 775
Chattanooga Group, Inc.
Physical Medicine
119d
Cleared
Oct 01, 1987
MYOSTIM(TM), MODEL 6600
Medical Devices, Inc.
Physical Medicine
80d
Cleared
Sep 24, 1987
INTELECT MODEL 575
Chattanooga Group, Inc.
Physical Medicine
79d
Cleared
Jun 16, 1987
DYNATRON 438
Henley Intl.
Physical Medicine
131d
Cleared
Dec 29, 1986
MYOPAC (TM), MODEL 9600
Medical Devices, Inc.
Physical Medicine
34d
Cleared
Dec 02, 1986
EMPI MODEL 712, LOGIX(TM), NMS
Empi
Physical Medicine
48d
Cleared
Jul 09, 1986
INTERSTIM 100 SYSTEM
Buckman Co., Inc.
Physical Medicine
105d
Cleared
Jun 10, 1986
RICH-MAR IF 200
Rich-Mar Corp.
Physical Medicine
215d
Cleared
Feb 12, 1986
EMPI MODEL 720 NMS
Empi
Physical Medicine
75d
Cleared
Feb 12, 1986
EMPI MODEL 730 NMS
Empi
Physical Medicine
75d
Cleared
Jul 01, 1985
MYOCARE PLUS DUAL CHANNEL STIMULATOR
3M Company
Physical Medicine
109d
Cleared
May 17, 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
Chattanooga Group, Inc.
Physical Medicine
85d
Cleared
Mar 05, 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
Excel Tech. , Ltd.
Physical Medicine
98d
Cleared
Feb 21, 1985
THE PROBE 100
Rich-Mar Corp.
Physical Medicine
94d
Cleared
Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
Intermedics, Inc.
Physical Medicine
74d