NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | NFO |
|---|---|
| Device Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Aura Glide (FC40) | Aura Medical, LLC | Dec 23, 2025 | SESE |
| K252146 | 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 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Oct 29, 2025 | SESE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | Oct 17, 2025 | SESE |
| K251034 | 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 | 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 | Sunny Plus (Sunny) | ShenB Co., Ltd. | Sep 18, 2025 | SESE |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | Sep 3, 2025 | SESE |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | Jul 18, 2025 | SESE |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | Jul 10, 2025 | SESE |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | May 23, 2025 | SESE |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | Apr 1, 2025 | SESE |
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | Mar 6, 2025 | SESE |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | Feb 10, 2025 | SESE |
| K243393 | 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 | Medi Lift Mask | Ya-Man, Ltd. | Jan 16, 2025 | SESE |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | Dec 19, 2024 | SESE |
| K242532 | BTL-785BNF-E | BTL Industries, Inc. | Dec 13, 2024 | SESE |
| K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | Jun 27, 2024 | SESE |
| K232242 | 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
