IPF · Stimulator, Muscle, Powered
Physical Medicine · 21 CFR 890.5850 · Class 2
Overview
| Product Code | IPF |
|---|---|
| Device Name | Stimulator, Muscle, Powered |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 545)
Showing 20 most recent of 545 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251083 | Compact II | Enraf-Nonius, B.V. | Sep 12, 2025 | SESE |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | Jun 4, 2025 | SESE |
| K241488 | TrainFES Advance | Trainfes | Feb 5, 2025 | SESE |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | Dec 19, 2024 | SESE |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | Oct 10, 2024 | SESE |
| K240234 | BTL-899MS | BTL Industries, Inc. | Aug 17, 2024 | SESE |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | Aug 2, 2024 | SESE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | May 16, 2024 | SESE |
| K233926 | accufit | Mettler Electronics Corporation | Mar 21, 2024 | SESE |
| K233485 | M-Wave | Zynex Medical, Inc. | Jan 26, 2024 | SESE |
| K232937 | BTL-899M | BTL Industries, Inc. | Dec 26, 2023 | SESE |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | Nov 24, 2023 | SESE |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | Nov 3, 2023 | SESE |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | Oct 10, 2023 | SESE |
| K223802 | accufit | Mettler Electronics Corporation | Oct 6, 2023 | SESE |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | Sep 29, 2023 | SESE |
| K230167 | BACK 4 | Swims America Corp | Sep 14, 2023 | SESE |
| K232334 | DEKA SIMON | El.En S.P.A. | Sep 1, 2023 | SESE |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | Jan 17, 2023 | SESE |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | Oct 21, 2022 | SESE |
Top Applicants
- Rich-Mar Corp. — 17 clearances
- Bloomex International, Inc. — 14 clearances
- Chattanooga Group, Inc. — 11 clearances
- Maximum Performance Technologies, Mpts, Inc. — 11 clearances
- Mettler Electronics Corp. — 11 clearances
