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
Cleared
Apr 08, 2016
geko(TM) Plus R-2 Neuromuscular Stimulator
Firstkind Limited
Physical Medicine
64d
Cleared
Feb 17, 2016
VitalStim(R) Plus Electrotherapy System
Djo, LLC
Physical Medicine
103d
Cleared
Oct 23, 2015
geko T-2 Neuromuscular Stimulator
Firstkind Limited
Physical Medicine
35d
Cleared
Jul 23, 2015
Muscle Stimulation System 110
Niveus Medical, Inc.
Physical Medicine
122d
Cleared
Apr 02, 2015
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
Cymedica Orthopedics, Inc.
Physical Medicine
43d
Cleared
Oct 07, 2014
FLEX-MT +
Emsi
Physical Medicine
225d
Cleared
Aug 21, 2014
GEKO
Firstkind Limited
Physical Medicine
267d
Cleared
Apr 29, 2014
NEURODYN COMPACT, NEURODYN II
Ibramed Equipamentos Medicos
Physical Medicine
307d
Cleared
Apr 10, 2014
VECTRA NEO CLINICAL THERAPY SYSTEM
Djo, LLC
Physical Medicine
261d
Cleared
Dec 20, 2013
TONE-A-MATIC
Tone-A-Matic International, Inc.
Physical Medicine
345d
Cleared
Dec 20, 2013
ELECTROTHERAPY DEVICE (COMBO UNIT)
Guangzhou Finecure Medical Equipment Co.,Ltd
Physical Medicine
282d
Cleared
Nov 26, 2013
NEURODYN MULTIWAVE, AUSSIE SPORT
Ibramed Equipamentos Medicos
Physical Medicine
175d
Cleared
Oct 31, 2013
AMPCARE ESP THERAPY SYSTEM
Ampcare, LLC
Physical Medicine
184d
Cleared
Sep 12, 2013
MULTISTIM
Metron Medical Australia, Pty, Ltd.
Physical Medicine
63d
Cleared
Jul 11, 2013
STIMEL-03
Stimel, Ltd.
Physical Medicine
141d
Cleared
Jun 28, 2013
REVITIVE IX
Actegy , Ltd.
Physical Medicine
240d
Cleared
May 06, 2013
EMPI PHOENIX
Djo, LLC
Physical Medicine
130d
Cleared
Mar 29, 2013
MUSCLE STIMULATION SYSTEM
Niveus Medical, Inc.
Physical Medicine
123d
Cleared
Feb 07, 2013
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Selectivemed Components, Inc.
Physical Medicine
317d
Cleared
Dec 21, 2012
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
Famidoc Technology Co., Ltd.
Physical Medicine
437d
Cleared
Jun 26, 2012
SYS*STIM 240
Mettler Electronics Corp.
Physical Medicine
259d
Cleared
Apr 30, 2012
POWERED MUSCLE STIMULATOR
Valmed, SA
Physical Medicine
278d
Cleared
Jan 19, 2012
RS-4I MUSCLE STIMULATOR
Rs Medical
Physical Medicine
156d
Cleared
Sep 20, 2011
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
Zynex Medical, Inc.
Physical Medicine
138d