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