Data / Medical devices / China / Zhengzhou Zhongkemei Health Technology Co., Ltd.
Zhengzhou Zhongkemei Health Technology Co., Ltd.: FDA-registered device maker in Shangjie District Henan, China, 1 510(k) clearance
Zhengzhou Zhongkemei Health Technology Co., Ltd. is registered with the FDA (registration 3029328624) in Shangjie District Henan, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029328624
- Address
- Room 928, 16th Floor, Unit 1, Building 1, No. 33 Jinshuo Road, Shangjie District Henan, China, 450000
- Owner or operator
- Zhengzhou Zhongkemei Health Technology Co., Ltd. (10095064)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer
- First device listed
- January 20, 2026
- Registered through
- 2026
- Brand names listed
- Hydrogen inhale machine, Red light therapy device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Rebreathing | BYW | 1 | Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | OHS | Substantially Equivalent | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Device, Rebreathing
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.