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
Declining activity - 9 submissions in the last 2 years vs 15 in the prior period
Review times increasing: avg 245d recently vs 156d historically

FDA 510(k) Cleared Stimulator, Muscle, Powered Devices (Product Code IPF)

547 devices
1–24 of 547
Cleared Jun 02, 2026
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K252816
Mohammadali Nezakati
Neurology · 271d
Cleared May 27, 2026
StimelMD (SSMD) system
K260142
Motion Informatics ltd.
Physical Medicine · 127d
Cleared Sep 12, 2025
Compact II
K251083
Enraf-Nonius, B.V.
Physical Medicine · 156d
Cleared Jun 04, 2025
EVE Synergy (EVE-20M)
K241433
Weero Co., Ltd.
Neurology · 379d
Cleared Feb 05, 2025
TrainFES Advance
K241488
Trainfes
Physical Medicine · 257d
Cleared Dec 19, 2024
Quantum Mitohormesis (QMT) (M2101)
K240348
Quantumtx Pte. , Ltd.
Physical Medicine · 318d
Cleared Oct 10, 2024
eMVFit (MVF-10M)
K240992
Weero Co., Ltd.
Physical Medicine · 182d
Cleared Aug 17, 2024
BTL-899MS
K240234
BTL Industries, Inc.
Physical Medicine · 201d
Cleared Aug 02, 2024
MYOTouch Muscle Stimulator
K233098
Sunmed, LLC
Physical Medicine · 311d
Cleared May 16, 2024
Stimulation System (PA series, PR series, S series and Q series)
K232786
Edan Instruments, Inc.
Physical Medicine · 248d
Cleared Mar 21, 2024
accufit
K233926
Mettler Electronics Corporation
Physical Medicine · 99d
Cleared Jan 26, 2024
M-Wave
K233485
Zynex Medical, Inc.
Physical Medicine · 91d
Cleared Dec 26, 2023
BTL-899M
K232937
BTL Industries, Inc.
Physical Medicine · 97d
Cleared Nov 24, 2023
Stim2Go
K230701
PAJUNK GmbH Medizintechnologie
Physical Medicine · 255d
Cleared Nov 03, 2023
Combo Electrotherapy Device
K231440
Shenzhen Roundwhale Technology Co. , Ltd.
Physical Medicine · 169d
Cleared Oct 10, 2023
NeuroTrigger Basic (NTB)
K223027
Neurotrigger
Physical Medicine · 376d
Cleared Oct 06, 2023
accufit
K223802
Mettler Electronics Corporation
Physical Medicine · 291d
Cleared Sep 29, 2023
StarFormer, TightWave
K221274
Fotona D.O.O.
Physical Medicine · 515d
Cleared Sep 14, 2023
BACK 4
K230167
Swims America Corp
Physical Medicine · 237d
Cleared Sep 01, 2023
DEKA SIMON
K232334
El.En S.P.A.
Physical Medicine · 28d
Cleared Jan 17, 2023
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
K213655
Hilltek, LLC
Physical Medicine · 424d
Cleared Oct 21, 2022
Flex-MI
K221958
Emsi, Inc.
Physical Medicine · 108d
Cleared Oct 21, 2022
Biological Feedback and Stimulation System
K222201
Medlander Medical Technology, Inc.
Physical Medicine · 88d
Cleared Oct 14, 2022
Shoulder PacemakerTM
K220994
Ncs Lab Srl
Physical Medicine · 193d

About Product Code IPF - Regulatory Context

510(k) Submission Activity

547 total 510(k) submissions under product code IPF since 1976, with 547 receiving FDA clearance (average review time: 157 days).

Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 15 in the prior period.

FDA 510(k) Review Time - IPF Product Code

Recent submissions under IPF have taken an average of 245 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.

IPF devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →