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
Cleared
Dec 10, 2003
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
Everyway Medical Instruments Co.,Ltd
Physical Medicine
30d
Cleared
Oct 29, 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
Everyway Medical Instruments Co.,Ltd
Physical Medicine
29d
Cleared
Oct 22, 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Rich-Mar Corp.
Physical Medicine
30d
Cleared
Aug 19, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
Biomedical Life Systems, Inc.
Physical Medicine
105d
Cleared
May 30, 2003
SYS*STIM 208 AND 208A
Mettler Electronics Corp.
Physical Medicine
60d
Cleared
Mar 28, 2003
VECTORSURGE 5 MODEL 470
Metron Medical Australia, Pty, Ltd.
Physical Medicine
28d
Cleared
Feb 13, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
Biomedical Life Systems, Inc.
Physical Medicine
275d
Cleared
Oct 31, 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
Everyway Medical Instruments Co.,Ltd
Physical Medicine
238d
Cleared
Jul 11, 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
Bio-Medical Research, Ltd.
Physical Medicine
217d
Cleared
Jun 28, 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
Apex Medical Corp.
Physical Medicine
30d
Cleared
Jun 18, 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
Empi
Physical Medicine
75d
Cleared
Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
Rich-Mar Corp.
Physical Medicine
66d
Cleared
Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Rich-Mar Corp.
Physical Medicine
66d
Cleared
Jan 18, 2002
BIO SPA INTELLIGENT
Starbene
Physical Medicine
942d
Cleared
Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
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
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
Apex Medical Corp.
Physical Medicine
360d
Cleared
Jun 06, 2001
SMITH & NEPHEW RESTIM
Smith & Nephew, Inc.
Physical Medicine
197d
Cleared
May 29, 2001
VECTORSURGE 5, MODEL VS-500
Metron Medical Australia, Pty, Ltd.
Physical Medicine
327d
Cleared
Feb 22, 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
Metron Medical Australia, Pty, Ltd.
Physical Medicine
127d
Cleared
Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
Rich-Mar Corp.
Physical Medicine
165d
Cleared
Jul 19, 2000
CONTROL SOLUTIONS INC, MODEL CS3101
Control Solutions, Inc.
Physical Medicine
281d
Cleared
Apr 10, 2000
HMS NEUROMUSCULAR STIMULATOR
Home Medical Services, Inc.
Physical Medicine
131d
Cleared
Apr 04, 2000
MS-ONE, MODEL MS-1
Home Wellness West
Physical Medicine
125d