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 Medtronic Vascular, Firstkind Limited and BTL Industries, Inc..

547
Total
547
Cleared
157d
Avg days
1976
Since
547 devices
25–48 of 547
Cleared Jun 17, 2022
MyOnyx System
K213197
Thought Technology , Ltd.
Physical Medicine · 261d
Cleared May 12, 2022
Motive Knee Wrap
K220738
Cymedica Orthopedics, Inc.
Physical Medicine · 59d
Cleared Mar 04, 2022
geko W-3
K220327
Firstkind Limited
Physical Medicine · 28d
Cleared Feb 25, 2022
Levator Elite (Model LE9011)
K213043
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 156d
Cleared Dec 14, 2021
TimeWaver Frequency
K212832
Timewaver Production GmbH
Physical Medicine · 98d
Cleared Nov 29, 2021
geko W-2
K212762
Firstkind Limited
Physical Medicine · 90d
Cleared Oct 19, 2021
MyoWorx TM20
K192746
Myoworx, Inc.
Physical Medicine · 750d
Cleared Oct 01, 2021
STELLA BIO
K210002
Egzotech Sp. Z O. O.
Physical Medicine · 270d
Cleared Aug 24, 2021
Shoulder Pacemaker
K210674
Ncs Lab Srl
Physical Medicine · 172d
Cleared Jul 30, 2021
PowerDot PD-01MT2 Muscle Stimulator
K210938
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 123d
Cleared Jul 08, 2021
Nerve and Muscle Stimulator
K211094
Shenzhen Xft Medical Limited
Physical Medicine · 87d
Cleared Jun 03, 2021
Intellihab System
K210604
Cymedica Orthopedics, Inc.
Physical Medicine · 94d
Cleared May 13, 2021
Prelivia
K210979
Rehabtronics, Inc.
Physical Medicine · 42d
Cleared May 11, 2021
Neurodyn V2.0, Neurodyn Aussie V2.0
K210572
Ibramed Equipamentos Medicos
Physical Medicine · 74d
Cleared May 06, 2021
Talent-Pro Electromagnetic Stimulator
K202031
Remed Co., Ltd.
Physical Medicine · 288d
Cleared May 03, 2021
Storz Medical MAGNETOLITH Muscle Stimulator
K203710
Storz Medical AG
Physical Medicine · 133d
Cleared Mar 05, 2021
InMode Evolve System with the Tone Applicator
K201285
Inmode , Ltd.
Physical Medicine · 296d
Cleared Feb 23, 2021
PowerDot PD-01MT2 Muscle Stimulator
K210269
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 22d
Cleared Feb 19, 2021
emField
K203488
Zimmer Medizinsysteme GmbH
Physical Medicine · 84d
Cleared Dec 08, 2020
Biofeedback Nerve and Muscle Stimulator
K202648
Shenzhen Konmed Technology Co., Ltd.
Physical Medicine · 88d
Cleared Nov 25, 2020
Physiq
K202079
El.En Electronic Engineering Spa
Physical Medicine · 121d
Cleared Nov 16, 2020
Avid CT2
K202490
Vision Quest Industries Inc./Dba VQ Orthocare
Neurology · 77d
Cleared Oct 29, 2020
g.Estim FES
K200088
G.Tec Medical Engineering GmbH
Physical Medicine · 288d
Cleared Sep 21, 2020
Medline DeNovo 4Pro Electrical Stimulation Device
K201290
Medline Industries, Inc.
Physical Medicine · 130d