Everyway
The listed MT-200 is the Everyway Facial MENS. Its FDA filing describes a single-channel transcutaneous electrical nerve stimulator for facial stimulation, with electrodes attached to the…
The listed MT-200 is the Everyway Facial MENS. Its FDA filing describes a single-channel transcutaneous electrical nerve stimulator for facial stimulation, with electrodes attached to the skin.
The filing says the device uses two fixed, smooth spherical probes to deliver microcurrent. It identifies over-the-counter cosmetic use as the intended use.
Listed Item
Stimulator, transcutaneous electrical, aesthetic purposes
Device Operation
The filing describes a nine-volt battery powered device and says polarity alternates between the probes. The user can set the output amplitude from zero to 400 microamps.
Who Else Makes It
Concentrated in Guangdong (19), Shanghai (1), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Guangdong Ace-Tec Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Foshan Shiding Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Zhongshan Kingdom Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| VIS (Shanghai) Technology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 10 |
Showing 12 of 22. All 22 manufacturers in China registered for Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Record
| Listed by | Everyway Medical Instruments Co., Ltd., Taiwan |
|---|---|
| FDA product code | NFO |
| Device type | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Manufacturer |
| 510(k) | K142794 |
| Record published | 2023-08-30 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT-200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech Gmbh | 13 |
| Ziip Beauty | Ziip Inc | 9 |
| NuFACE | Nuface | 9 |
| MicroCurrent Face-Lifter 6 in 1 | Geske Beauty Tech Gmbh | 5 |
| Jianchao Smart | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 5 |
| Medi Lift | YA-MAN Ltd. | 5 |
| Jmoon | Shenzhen Ulike Smart Electronics Co., Ltd. | 5 |
| Nuon | Shenzhen Nuon Medical Equipment Co., Ltd. | 4 |
| Purelift | Xtreem Pulse | 4 |
| Johari Digital Healthcare Ltd. | Syrma Johari MedTech Limited | 4 |
| Bear 2 | Foreo Inc | 3 |
| Micro-current Facial Beauty Device | Shenzhen Aozemei Technology Co., Ltd. | 3 |
Showing 12 of 56. All products under Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142794 | 2015-06-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.