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 Firstkind Limited, Medtronic Vascular and Smartmissimo Technologies Pte, Ltd..

547
Total
547
Cleared
157d
Avg days
1976
Since
547 devices
49–72 of 547
Cleared Aug 04, 2020
ETD Family of Electrotherapy Devices
K201958
Therasigma, LLC
Physical Medicine · 21d
Cleared Apr 11, 2020
Nerve and Muscle Stimulator
K193275
Shenzhen Xft Medical Limited
Physical Medicine · 137d
Cleared Jan 18, 2020
geko™ W-2
K193045
Firstkind Limited
Physical Medicine · 78d
Cleared Jan 11, 2020
TENS and EMS Stimulator, TENS Stimulator
K183074
Astek Technology , Ltd.
Physical Medicine · 432d
Cleared Dec 23, 2019
RelieforMe TENS/EMS Device Model UPK-GE01
K192733
Umeheal , Ltd.
Physical Medicine · 87d
Cleared Dec 17, 2019
InMode System with Tone Applicator
K192249
Inmode , Ltd.
Physical Medicine · 120d
Cleared Sep 18, 2019
geko T-2 and geko T-3 Neuromuscular Stimulators
K191113
Firstkind Limited
Physical Medicine · 145d
Cleared Jul 09, 2019
Shear Stress Therapeutics SST 3000
K182163
Shear Stress Therapeutics, LLC
Physical Medicine · 333d
Cleared Nov 09, 2018
PowerDot PD-01MT
K181759
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 130d
Cleared Sep 07, 2018
R-C1 TENS and EMS Stimulator
K181688
Shenzhen Roundwhale Technology Co. , Ltd.
Physical Medicine · 73d
Cleared May 23, 2018
geko T-3 Neuromuscular Stimulator
K181059
Firstkind Limited
Physical Medicine · 30d
Cleared Mar 06, 2018
Digitimer DS7AP Constant Current Stimulator
K172381
Digitimer , Ltd.
Physical Medicine · 211d
Cleared Feb 11, 2018
geko T-2 and geko Plus R-2
K180082
Firstkind, Ltd.
Physical Medicine · 31d
Cleared Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 94d
Cleared Oct 21, 2016
HPM-6000
K160992
BTL Industries, Inc.
Physical Medicine · 196d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared May 19, 1994
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared May 20, 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436
Medtronic Vascular
Physical Medicine · 107d
Cleared Jul 01, 1985
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046
3M Company
Physical Medicine · 109d
Cleared Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
K841647
Intermedics, Inc.
Physical Medicine · 74d
Cleared Feb 17, 1984
NEUROMUSCULAR STIMULATOR 3105
K840467
Medtronic Vascular
Physical Medicine · 14d
Cleared Nov 22, 1982
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279
Medtronic Vascular
Physical Medicine · 19d
Cleared Dec 02, 1981
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008
Medtronic Vascular
Physical Medicine · 36d
Cleared Dec 31, 1980
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064
Zimmer, Inc.
Physical Medicine · 27d