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-staging.innolitics.com/productcode/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 81)

Showing 20 most recent of 81 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262861](/device/K262861.md) | PureLift Pro Max | Xtreem Pulse, LLC | Sep 11, 2026 | SESE |
| [K260387](/device/K260387.md) | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | Aug 31, 2026 | SESE |
| [K253932](/device/K253932.md) | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jul 23, 2026 | SESE |
| [K260179](/device/K260179.md) | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Jun 3, 2026 | SESE |
| [K260895](/device/K260895.md) | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | May 28, 2026 | SESE |
| [K252621](/device/K252621.md) | DeepSkin (DEP100) | El Global Trade, Ltd. | May 8, 2026 | SESE |
| [K252187](/device/K252187.md) | Aura Glide  (FC40) | Aura Medical, LLC | Dec 23, 2025 | SESE |
| [K252146](/device/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](/device/K250618.md) | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Oct 29, 2025 | SESE |
| [K250227](/device/K250227.md) | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | Oct 17, 2025 | SESE |
| [K251034](/device/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](/device/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](/device/K251649.md) | Sunny Plus (Sunny) | ShenB Co., Ltd. | Sep 18, 2025 | SESE |
| [K251909](/device/K251909.md) | NeurotriS  (SX2500); NeurotriS (SX3800) | A-1 Engineering | Sep 3, 2025 | SESE |
| [K252218](/device/K252218.md) | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | Jul 18, 2025 | SESE |
| [K244004](/device/K244004.md) | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | Jul 10, 2025 | SESE |
| [K250361](/device/K250361.md) | SmartAppGuidedTM MicroCurrent Face-Lift Pen  6 in 1 | Geske Beauty Tech GmbH | May 23, 2025 | SESE |
| [K243072](/device/K243072.md) | Préime DermaFacial  (MicroT) | EMA Aesthetics , Ltd. | Apr 1, 2025 | SESE |
| [K243587](/device/K243587.md) | PureLift GLOW | Xtreem Pulse, LLC | Mar 6, 2025 | SESE |
| [K243063](/device/K243063.md) | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | Feb 10, 2025 | SESE |

## Top Applicants

- Carol Cole Company Dba Nuface — 6 clearances
- Carol Cole Company — 4 clearances
- Micro Current Technology, Inc. — 4 clearances
- Xtreem Pulse, LLC — 4 clearances
- Ya-Man, Ltd. — 3 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/NFO](https://fda-staging.innolitics.com/productcode/NFO)

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**Cite:** Innolitics at https://innolitics.com