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
73–96 of 548
Cleared Apr 08, 2016
geko(TM) Plus R-2 Neuromuscular Stimulator
K160299
Firstkind Limited
Physical Medicine · 64d
Cleared Feb 17, 2016
VitalStim(R) Plus Electrotherapy System
K153224
Djo, LLC
Physical Medicine · 103d
Cleared Oct 23, 2015
geko T-2 Neuromuscular Stimulator
K152677
Firstkind Limited
Physical Medicine · 35d
Cleared Jul 23, 2015
Muscle Stimulation System 110
K150742
Niveus Medical, Inc.
Physical Medicine · 122d
Cleared Apr 02, 2015
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
K150413
Cymedica Orthopedics, Inc.
Physical Medicine · 43d
Cleared Oct 07, 2014
FLEX-MT +
K140467
Emsi
Physical Medicine · 225d
Cleared Aug 21, 2014
GEKO
K133638
Firstkind Limited
Physical Medicine · 267d
Cleared Apr 29, 2014
NEURODYN COMPACT, NEURODYN II
K131917
Ibramed Equipamentos Medicos
Physical Medicine · 307d
Cleared Apr 10, 2014
VECTRA NEO CLINICAL THERAPY SYSTEM
K132284
Djo, LLC
Physical Medicine · 261d
Cleared Dec 20, 2013
TONE-A-MATIC
K130052
Tone-A-Matic International, Inc.
Physical Medicine · 345d
Cleared Dec 20, 2013
ELECTROTHERAPY DEVICE (COMBO UNIT)
K130691
Guangzhou Finecure Medical Equipment Co.,Ltd
Physical Medicine · 282d
Cleared Nov 26, 2013
NEURODYN MULTIWAVE, AUSSIE SPORT
K131629
Ibramed Equipamentos Medicos
Physical Medicine · 175d
Cleared Oct 31, 2013
AMPCARE ESP THERAPY SYSTEM
K131222
Ampcare, LLC
Physical Medicine · 184d
Cleared Sep 12, 2013
MULTISTIM
K132137
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 63d
Cleared Jul 11, 2013
STIMEL-03
K130424
Stimel, Ltd.
Physical Medicine · 141d
Cleared Jun 28, 2013
REVITIVE IX
K123354
Actegy , Ltd.
Physical Medicine · 240d
Cleared May 06, 2013
EMPI PHOENIX
K124016
Djo, LLC
Physical Medicine · 130d
Cleared Mar 29, 2013
MUSCLE STIMULATION SYSTEM
K123642
Niveus Medical, Inc.
Physical Medicine · 123d
Cleared Feb 07, 2013
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
K120922
Selectivemed Components, Inc.
Physical Medicine · 317d
Cleared Dec 21, 2012
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113010
Famidoc Technology Co., Ltd.
Physical Medicine · 437d
Cleared Jun 26, 2012
SYS*STIM 240
K113017
Mettler Electronics Corp.
Physical Medicine · 259d
Cleared Apr 30, 2012
POWERED MUSCLE STIMULATOR
K112148
Valmed, SA
Physical Medicine · 278d
Cleared Jan 19, 2012
RS-4I MUSCLE STIMULATOR
K112348
Rs Medical
Physical Medicine · 156d
Cleared Sep 20, 2011
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
K111279
Zynex Medical, Inc.
Physical Medicine · 138d