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
May 07, 1984
EMPI MODEL 712, LOGIX, NMS
Empi
Physical Medicine
35d
Cleared
Apr 24, 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
Richards Medical Co., Inc.
Physical Medicine
57d
Cleared
Feb 17, 1984
NEUROMUSCULAR STIMULATOR 3105
Medtronic Vascular
Physical Medicine
14d
Cleared
Feb 10, 1984
NEUROMUSCLAR II
Mentor Corp.
Physical Medicine
15d
Cleared
Mar 10, 1983
RICH-MAR HV 20
Rich-Mar Corp.
Physical Medicine
57d
Cleared
Nov 22, 1982
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
Medtronic Vascular
Physical Medicine
19d
Cleared
Feb 24, 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
Mentor Corp.
Physical Medicine
34d
Cleared
Jan 29, 1982
HIGH VOLTAGE GALVANIC STIMULATOR 550
Chattanooga Group, Inc.
Physical Medicine
63d
Cleared
Dec 02, 1981
RESPOND II...NEUROMUSCULAR STIMULATOR
Medtronic Vascular
Physical Medicine
36d
Cleared
Aug 24, 1981
EMPI MODEL 710, NMS
Empi
Physical Medicine
98d
Cleared
Dec 31, 1980
ZIMMER ELECTRICAL MUSCLE STIMULATOR
Zimmer, Inc.
Physical Medicine
27d
Cleared
Aug 20, 1980
INTELECT
Chattanooga Group, Inc.
Physical Medicine
22d
Cleared
May 02, 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
Medtronic Vascular
Physical Medicine
59d
Cleared
Sep 26, 1978
MUSCLE STIMULATOR, ELECTRICAL
Rich-Mar Corp.
Physical Medicine
85d
Cleared
Sep 15, 1978
STEMPLEX
Rich-Mar Corp.
Physical Medicine
64d