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
145–168 of 548
Cleared Dec 09, 1999
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
K993821
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 27d
Cleared Nov 02, 1999
IF8000
K991241
Dan Med, Inc.
Physical Medicine · 204d
Cleared Oct 20, 1999
TRIO 300
K990787
Ito Co., Ltd.
Physical Medicine · 224d
Cleared Jun 18, 1999
RS-4V MUSCLE STIMULATOR
K990697
Rs Medical
Physical Medicine · 107d
Cleared Feb 09, 1999
SYS STIM 294, MODEL ME 294
K984114
Mettler Electronics Corp.
Physical Medicine · 84d
Cleared Feb 09, 1999
SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
K984142
Mettler Electronics Corp.
Physical Medicine · 83d
Cleared Jan 28, 1999
MS300
K984021
Lsi Intl., Inc.
Physical Medicine · 77d
Cleared Jan 28, 1999
MS400
K984113
Lsi Intl., Inc.
Physical Medicine · 72d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Sep 30, 1998
HANDMASTER NMS1
K982482
N.E.S.S. Nuromuscular Electrical Stimulation Syst
Physical Medicine · 76d
Cleared Sep 14, 1998
SURGI STIM
K982388
Vision Quest Industries, Inc.
Physical Medicine · 67d
Cleared Jul 28, 1998
MYO-TRAIN V (5)
K980158
Sterne Equipment Co., Ltd.
Physical Medicine · 193d
Cleared Jul 13, 1998
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040
Nisha Communication Industries
Physical Medicine · 189d
Cleared May 21, 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929
Neotonus, Inc.
Physical Medicine · 218d
Cleared May 11, 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892
Alive, Inc.
Physical Medicine · 63d
Cleared May 11, 1998
HAKOMED ELECDT/VACUPULLS
K980958
Alive, Inc.
Physical Medicine · 56d
Cleared Apr 28, 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346
Universal Technology Systems, Inc.
Physical Medicine · 90d
Cleared Apr 03, 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448
Radionics, Inc.
Physical Medicine · 57d
Cleared Feb 18, 1998
STELLAR MODEL HS-04
K973223
Stellar Medical Corp.
Physical Medicine · 175d
Cleared Nov 10, 1997
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997
Dan Med, Inc.
Physical Medicine · 90d
Cleared Oct 09, 1997
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434
Skylark Device Co., Ltd.
Physical Medicine · 338d
Cleared Sep 25, 1997
W.M.E. GPS 1001
K961751
Weaver Medical Electronics, Inc.
Physical Medicine · 507d
Cleared Sep 10, 1997
IMPULSE HVG
K970847
Armstrong Industries, Inc.
Physical Medicine · 187d
Cleared Aug 29, 1997
MSI MAGNA-STYM
K972055
Microvas Systems, Inc.
Physical Medicine · 88d