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
Cleared
May 22, 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
Rich-Mar Corp.
Physical Medicine
87d
Cleared
May 20, 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
Medtronic Vascular
Physical Medicine
107d
Cleared
Dec 18, 1991
RICH-MAR IFV 1000
Rich-Mar Corp.
Physical Medicine
68d
Cleared
Dec 09, 1991
EMS300, EMS400, EMS8000
Skylark Device Co., Ltd.
Physical Medicine
178d
Cleared
Oct 22, 1990
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
Chattanooga Group, Inc.
Physical Medicine
132d
Cleared
Jun 26, 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
Rich-Mar Corp.
Physical Medicine
70d
Cleared
Apr 16, 1990
SIEMENS STEREODYNATOR 828
Elmed, Inc.
Physical Medicine
741d
Cleared
Mar 26, 1990
ISOTRON 220
Excel Tech. , Ltd.
Physical Medicine
34d
Cleared
Mar 07, 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
Chattanooga Group, Inc.
Physical Medicine
43d
Cleared
Feb 20, 1990
EMS 8100
Henley Intl.
Physical Medicine
179d
Cleared
Feb 20, 1990
MULTISTIM PLUS
Excel Tech. , Ltd.
Physical Medicine
148d
Cleared
Feb 20, 1990
EXCEL STIM
Excel Tech. , Ltd.
Physical Medicine
99d
Cleared
Dec 19, 1989
SYS*STIM 206A
Mettler Electronics Corp.
Physical Medicine
207d
Cleared
Dec 19, 1989
SYS*STIM 207A
Mettler Electronics Corp.
Physical Medicine
207d
Cleared
Dec 14, 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
Rich-Mar Corp.
Physical Medicine
192d
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
Mar 10, 1988
SIEMENS NEUROTON 826 AND 827
Elmed, Inc.
Physical Medicine
79d
Cleared
Feb 24, 1988
INTELECT VMS 2, OR INTELECT VMS II
Chattanooga Group, Inc.
Physical Medicine
35d
Cleared
Jan 22, 1988
MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
Futuremed Div. of Future Impex Corp.
Physical Medicine
288d