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
241–264 of 548
Cleared Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
K841647
Intermedics, Inc.
Physical Medicine · 74d
Cleared May 07, 1984
EMPI MODEL 712, LOGIX, NMS
K841382
Empi
Physical Medicine · 35d
Cleared Apr 24, 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895
Richards Medical Co., Inc.
Physical Medicine · 57d
Cleared Feb 17, 1984
NEUROMUSCULAR STIMULATOR 3105
K840467
Medtronic Vascular
Physical Medicine · 14d
Cleared Feb 10, 1984
NEUROMUSCLAR II
K840346
Mentor Corp.
Physical Medicine · 15d
Cleared Mar 10, 1983
RICH-MAR HV 20
K830055
Rich-Mar Corp.
Physical Medicine · 57d
Cleared Nov 22, 1982
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279
Medtronic Vascular
Physical Medicine · 19d
Cleared Jun 23, 1982
HETERODYNAMIC
K821157
Birtcher Corp.
Physical Medicine · 62d
Cleared Feb 24, 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168
Mentor Corp.
Physical Medicine · 34d
Cleared Jan 29, 1982
HIGH VOLTAGE GALVANIC STIMULATOR 550
K813456
Chattanooga Group, Inc.
Physical Medicine · 63d
Cleared Dec 02, 1981
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008
Medtronic Vascular
Physical Medicine · 36d
Cleared Aug 24, 1981
EMPI MODEL 710, NMS
K811395
Empi
Physical Medicine · 98d
Cleared Dec 31, 1980
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064
Zimmer, Inc.
Physical Medicine · 27d
Cleared Aug 20, 1980
INTELECT
K801790
Chattanooga Group, Inc.
Physical Medicine · 22d
Cleared May 02, 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484
Medtronic Vascular
Physical Medicine · 59d
Cleared Feb 09, 1979
HVG-100
K790033
Elmed, Inc.
Physical Medicine · 37d
Cleared Sep 26, 1978
MUSCLE STIMULATOR, ELECTRICAL
K781113
Rich-Mar Corp.
Physical Medicine · 85d
Cleared Sep 15, 1978
STEMPLEX
K781167
Rich-Mar Corp.
Physical Medicine · 64d
Cleared Dec 17, 1976
TECA MODEL SP5/T ELECTRO-THER. STIM.
K761220
Teca, Inc.
Physical Medicine · 10d