Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5850](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5850) → IPF — Stimulator, Muscle, Powered # IPF · Stimulator, Muscle, Powered _Physical Medicine · 21 CFR 890.5850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF ## Overview - **Product Code:** IPF - **Device Name:** Stimulator, Muscle, Powered - **Regulation:** [21 CFR 890.5850](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5850) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K251083.md) | Compact II | Enraf-Nonius, B.V. | Sep 12, 2025 | SESE | | [K241433](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K241433.md) | EVE Synergy (EVE-20M) | Weero Co., Ltd. | Jun 4, 2025 | SESE | | [K241488](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K241488.md) | TrainFES Advance | Trainfes | Feb 5, 2025 | SESE | | [K240348](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K240348.md) | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | Dec 19, 2024 | SESE | | [K240992](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K240992.md) | eMVFit (MVF-10M) | Weero Co., Ltd. | Oct 10, 2024 | SESE | | [K240234](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K240234.md) | BTL-899MS | BTL Industries, Inc. | Aug 17, 2024 | SESE | | [K233098](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K233098.md) | MYOTouch Muscle Stimulator | Sunmed, LLC | Aug 2, 2024 | SESE | | [K232786](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K232786.md) | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | May 16, 2024 | SESE | | [K233926](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K233926.md) | accufit | Mettler Electronics Corporation | Mar 21, 2024 | SESE | | [K233485](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K233485.md) | M-Wave | Zynex Medical, Inc. | Jan 26, 2024 | SESE | | [K232937](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K232937.md) | BTL-899M | BTL Industries, Inc. | Dec 26, 2023 | SESE | | [K230701](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K230701.md) | Stim2Go | PAJUNK GmbH Medizintechnologie | Nov 24, 2023 | SESE | | [K231440](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K231440.md) | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | Nov 3, 2023 | SESE | | [K223027](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K223027.md) | NeuroTrigger Basic (NTB) | Neurotrigger | Oct 10, 2023 | SESE | | [K223802](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K223802.md) | accufit | Mettler Electronics Corporation | Oct 6, 2023 | SESE | | [K221274](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K221274.md) | StarFormer, TightWave | Fotona D.O.O. | Sep 29, 2023 | SESE | | [K230167](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K230167.md) | BACK 4 | Swims America Corp | Sep 14, 2023 | SESE | | [K232334](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K232334.md) | DEKA SIMON | El.En S.P.A. | Sep 1, 2023 | SESE | | [K213655](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K213655.md) | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | Jan 17, 2023 | SESE | | [K222201](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K222201.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com