Purelift

The PureLift Pro Edition device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the…

Registry build 21.09.26

The PureLift Pro Edition device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Edition unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.

22manufacturers in China registered for this device type
4catalogue numbers in this listing
4510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code NFO
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

Regulatory record for Purelift
Listed by Xtreem Pulse, United States
FDA product code NFO
Device type Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class Class 2
Regulation 21 CFR 882.5890
Establishment Specification developer, Manufacturer
510(k) K190269
Record published 2023-09-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Storage Handling environment atmospheric pressure 700 to 1060 KiloPascal; Handling environment humidity 10 to 95 % RH; Handling environment temperature 10 to 45 °C
Sizes Height 20.7 cm; width 4.8 cm; outer diameter 4.5 cm; height 1.4 in; width 4.8 in; outer diameter 4.3 in

Catalogue Numbers

Catalogue numbers for Purelift
Catalogue number Size Status
PRO EDITION Height 20.7 cm In distribution
FACE Height 1.4 in In distribution
PRO PLUS Height 20.7 cm In distribution
PRO Height 20.7 cm In distribution

Same Product Code

Other products under the same FDA 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
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
Fynelook Shenzhen Dachi Communication Co., Ltd. 3

Showing 12 of 56. All products under Stimulator, Transcutaneous Electrical, Aesthetic Purposes

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243587 2025-03-06
K230506 2023-06-21
K221443 2022-10-21
K190269 2019-08-28

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer