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
Sep 21, 2020
Medline DeNovo 4Pro Electrical Stimulation Device
Medline Industries, Inc.
Physical Medicine
130d
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
Aug 09, 2017
StimSox(TM) System
Stimmed, LLC
Physical Medicine
121d
Cleared
May 31, 2017
EMS100 Tri-Wave Combination Stimulator
Elite Medical Supply of New York, LLC
Physical Medicine
20d
Cleared
Apr 10, 2017
geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
Firstkind Limited
Physical Medicine
153d
Cleared
Feb 14, 2017
FA100 SCCD (Sequential Continuous Contraction Device)
Flowaid Medical Technologies, Corp
Physical Medicine
110d
Cleared
Dec 16, 2016
Xcite Clinical Station
Restorative Therapies, Inc.
Physical Medicine
288d
Cleared
Dec 01, 2016
CyMedica e-vive™ System
Cymedica Orthopedics, Inc.
Physical Medicine
29d
Cleared
Oct 21, 2016
HPM-6000
BTL Industries, Inc.
Physical Medicine
196d
Cleared
Apr 15, 2016
StimSox(TM) System
Stimmed, LLC
Physical Medicine
277d
Cleared
Apr 14, 2016
Chattanooga Revolution Wireless
Djo, LLC
Physical Medicine
113d