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…
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.
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.
| 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
| 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
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Hi-TENS | In distribution | |
| BACK4 | In distribution | |
| BACK3TX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Human Tecar | Unibell SRL | 32 |
| Supercharge Hydra Fascia Electrodes | Unibell SRL | 9 |
| Capenergy | Capenergy Medical SL | 5 |
| Zionic Aesthetic | Termosalud SL | 4 |
| Pellefirm Handpiece | Cynosure, LLC | 3 |
| Emface controller | Btl Industries, Ltd. | 2 |
| Venus Legacy | Venus Concept Ltd. | 2 |
| Venus Legacy kit | Venus Concept Ltd. | 2 |
| OptiPLUS | Bios | 2 |
| Nuera Tight | Bios | 2 |
| Venus Legacy (120V) | Venus Concept Ltd. | 1 |
| Indiba Deep Care – Elite NS | Indiba | 1 |
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.