Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes # NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes _Neurology · 21 CFR 882.5890 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO ## Overview - **Product Code:** NFO - **Device Name:** Stimulator, Transcutaneous Electrical, Aesthetic Purposes - **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 75) Showing 20 most recent of 75 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252187](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K252187.md) | Aura Glide (FC40) | Aura Medical, LLC | Dec 23, 2025 | SESE | | [K252146](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K252146.md) | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | Dec 23, 2025 | SESE | | [K250618](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K250618.md) | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Oct 29, 2025 | SESE | | [K250227](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K250227.md) | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | Oct 17, 2025 | SESE | | [K251034](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K251034.md) | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | Oct 12, 2025 | SESE | | [K252553](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K252553.md) | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Oct 9, 2025 | SESE | | [K251649](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K251649.md) | Sunny Plus (Sunny) | ShenB Co., Ltd. | Sep 18, 2025 | SESE | | [K251909](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K251909.md) | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | Sep 3, 2025 | SESE | | [K252218](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K252218.md) | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | Jul 18, 2025 | SESE | | [K244004](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K244004.md) | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | Jul 10, 2025 | SESE | | [K250361](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K250361.md) | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | May 23, 2025 | SESE | | [K243072](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K243072.md) | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | Apr 1, 2025 | SESE | | [K243587](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K243587.md) | PureLift GLOW | Xtreem Pulse, LLC | Mar 6, 2025 | SESE | | [K243063](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K243063.md) | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | Feb 10, 2025 | SESE | | [K243393](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K243393.md) | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co., Ltd. | Feb 3, 2025 | SESE | | [K244048](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K244048.md) | Medi Lift Mask | Ya-Man, Ltd. | Jan 16, 2025 | SESE | | [K243430](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K243430.md) | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | Dec 19, 2024 | SESE | | [K242532](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K242532.md) | BTL-785BNF-E | BTL Industries, Inc. | Dec 13, 2024 | SESE | | [K240564](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K240564.md) | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | Jun 27, 2024 | SESE | | [K232242](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO/K232242.md) | BEAR 2 Body | Foreo, Inc. | May 13, 2024 | SESE | ## Top Applicants - Carol Cole Company Dba Nuface — 6 clearances - Carol Cole Company — 4 clearances - Micro Current Technology, Inc. — 4 clearances - Xtreem Pulse, LLC — 3 clearances - Ya-Man, Ltd. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NFO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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