Thermi 250
Catalogue number APMD115C, listed by Bios, United States, under Massager, Vacuum, Radio Frequency Induced Heat. 13 manufacturers in China are registered for this product code.
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 | Bios, United States |
|---|---|
| FDA product code | PBX |
| Device type | Massager, Vacuum, Radio Frequency Induced Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K151296 |
| Record published | 2016-09-29 |
| Record revised | 2025-06-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APMD115C | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bios S.R.L. | 510(k) number | 2017-07-13 | Class II | Software design | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | 167 units | 2020-09-15 |
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.