Apollo Duet
Apollo Duet’s RF mode delivers bipolar radiofrequency energy through four handpiece electrodes. It is intended for relief of minor muscle aches, pain and spasm, and temporary improvement of…
Apollo Duet’s RF mode delivers bipolar radiofrequency energy through four handpiece electrodes. It is intended for relief of minor muscle aches, pain and spasm, and temporary improvement of local circulation in adults.
The handpiece connects to the main body by an electrode cable, with a power adapter supplying the system. Its RF output operates at 1 MHz with a maximum power of 40 W.
Listed Item
Pain management device with multipolar RF
Temperature Control
A sensor in the RF handpiece monitors skin-surface temperature. Output shuts off automatically when the measured temperature exceeds 45°C. These controls belong to the RF configuration used in a hospital or clinic; the four electrodes deliver the energy in a bipolar arrangement.
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 | Weero 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 |
| 510(k) | K212253 |
| Record published | 2023-03-13 |
| Record revised | 2023-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ADP-4000 | 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 |
| Winback | Winback GO East Co Ltd | 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 |
Showing 12 of 150. All products under Massager, Vacuum, Radio Frequency Induced Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253261 | 2026-03-13 |
| K240991 | 2024-10-09 |
| K212253 | 2022-08-25 |
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.