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., Chattanooga Group, Inc. and Mettler Electronics Corp..

548
Total
548
Cleared
157d
Avg days
1976
Since
548 devices
121–144 of 548
Cleared Dec 10, 2003
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 30d
Cleared Oct 29, 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 29d
Cleared Oct 22, 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941
Rich-Mar Corp.
Physical Medicine · 30d
Cleared Aug 19, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427
Biomedical Life Systems, Inc.
Physical Medicine · 105d
Cleared May 30, 2003
SYS*STIM 208 AND 208A
K031017
Mettler Electronics Corp.
Physical Medicine · 60d
Cleared Mar 28, 2003
VECTORSURGE 5 MODEL 470
K030648
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Feb 13, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588
Biomedical Life Systems, Inc.
Physical Medicine · 275d
Cleared Oct 31, 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 238d
Cleared Jul 11, 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019
Bio-Medical Research, Ltd.
Physical Medicine · 217d
Cleared Jun 28, 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754
Apex Medical Corp.
Physical Medicine · 30d
Cleared Jun 18, 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100
Empi
Physical Medicine · 75d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
BIO SPA INTELLIGENT
K992099
Starbene
Physical Medicine · 942d
Cleared Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749
Biomedical Life Systems, Inc.
Physical Medicine · 199d
Cleared Aug 24, 2001
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
K002339
Apex Medical Corp.
Physical Medicine · 388d
Cleared Jul 27, 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
K002336
Apex Medical Corp.
Physical Medicine · 360d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared May 29, 2001
VECTORSURGE 5, MODEL VS-500
K002058
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 327d
Cleared Feb 22, 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 127d
Cleared Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808
Rich-Mar Corp.
Physical Medicine · 165d
Cleared Jul 19, 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420
Control Solutions, Inc.
Physical Medicine · 281d
Cleared Apr 10, 2000
HMS NEUROMUSCULAR STIMULATOR
K994062
Home Medical Services, Inc.
Physical Medicine · 131d
Cleared Apr 04, 2000
MS-ONE, MODEL MS-1
K994065
Home Wellness West
Physical Medicine · 125d