Winback

The BACK 3TX device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a…

Registry build 21.09.26

The BACK 3TX device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive or resistive monopolar modes and a multipolar mode. The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz. The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz). The two RF and EMS technologies should not be used in combination or sequentially. An emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

13manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (10), Beijing (2), Henan (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PBX
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hong Qiangxing (Shen Zhen) Electronics Limited Shenzhen Guangdong Contract manufacturer 19
Beijing Winkonlaser Technology Limited Beijing Beijing Contract manufacturer 14
Beijing Beautemax Technology Limited Beijing Beijing Contract manufacturer 13
Shen Zhen HanShine Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen Jie Zhong Lian Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Guangdong Fuqiang Beauty Equipment Co., Limited Qingyuan Guangdong Manufacturer 13
Shenzhen Rainbow Technology Co., Ltd. Shenzhen Guangdong Manufacturer 12
Shenzhen Margotan Tech Co., Ltd. Shenzhen Guangdong Manufacturer 10
Zhengzhou PZ Laser Slim Technology Co., Ltd. Zhengzhou Henan Manufacturer 6
Shenzhen Leaflife Technology Co., Ltd. Shenzhen Guangdong Manufacturer 5

Showing 12 of 13. All 13 manufacturers in China registered for Massager, Vacuum, Radio Frequency Induced Heat

Record

Regulatory record for Winback
Listed by Winback GO East Co Ltd, South Korea
FDA product code PBX
Device type Massager, Vacuum, Radio Frequency Induced Heat
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Manufacturer, Exporter
510(k) K220014
Record published 2025-07-23
Record revised 2026-05-18 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Winback
Catalogue number Size Status
Hi-TENS In distribution
BACK4 In distribution
BACK3TX In distribution

Same Product Code

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Showing 12 of 150. All products under Massager, Vacuum, Radio Frequency Induced Heat

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