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) → NGX — Stimulator, Muscle, Powered, For Muscle Conditioning # NGX · Stimulator, Muscle, Powered, For Muscle Conditioning _Physical Medicine · 21 CFR 890.5850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX ## Overview - **Product Code:** NGX - **Device Name:** Stimulator, Muscle, Powered, For Muscle Conditioning - **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 162) Showing 20 most recent of 162 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253926](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K253926.md) | Diacore | ShenB Co., Ltd. | Apr 10, 2026 | SESE | | [K253636](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K253636.md) | Zionic Pro Max (EMS) | Termosalud S.L. | Mar 12, 2026 | SESE | | [K253408](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K253408.md) | CoolTone | Zimmer Medizinsysteme GmbH | Jan 16, 2026 | SESE | | [K252154](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K252154.md) | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | Dec 9, 2025 | SESE | | [K253478](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K253478.md) | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | Nov 6, 2025 | SESE | | [K251594](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K251594.md) | truFlex | Syrma Johari Medtech Limited | Aug 28, 2025 | SESE | | [K251706](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K251706.md) | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Jul 30, 2025 | SESE | | [K251378](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K251378.md) | CoolTone | Zimmer Medizinsysteme GmbH | Jul 14, 2025 | SESE | | [K251746](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K251746.md) | Pure Impact | Sofwave Medical, Ltd. | Jul 2, 2025 | SESE | | [K250759](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K250759.md) | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | Jun 13, 2025 | SESE | | [K242926](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K242926.md) | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | May 30, 2025 | SESE | | [K250038](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K250038.md) | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | May 19, 2025 | SESE | | [K243165](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K243165.md) | Limfa Therapy System (Limfa Therapy) | Eywa Srl | May 15, 2025 | SESE | | [K250146](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K250146.md) | SofWave System | Sofwave Medical, Ltd. | Apr 18, 2025 | SESE | | [K243763](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K243763.md) | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Mar 12, 2025 | SESE | | [K241601](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K241601.md) | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | Feb 25, 2025 | SESE | | [K243511](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K243511.md) | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Feb 10, 2025 | SESE | | [K233770](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K233770.md) | Pepper EMS Training System | Pepper Interactive, Inc. | Jan 16, 2025 | SESE | | [K242787](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K242787.md) | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | Dec 18, 2024 | SESE | | [K232982](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX/K232982.md) | EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. | Nov 25, 2024 | SESE | ## Top Applicants - Bio-Medical Research, Ltd. — 13 clearances - Zimmer Medizinsysteme GmbH — 6 clearances - Actegy , Ltd. — 5 clearances - Changsha Anxiang Medical Technology Co., Ltd. — 5 clearances - BTL Industries, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NGX) **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