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