Data / Medical devices / China / Huizhou Xinyi Technology Co., Ltd
Huizhou Xinyi Technology Co., Ltd: FDA-registered device maker in Huizhou Guangdong, China, 2 510(k) clearances
Huizhou Xinyi Technology Co., Ltd is registered with the FDA (registration 3023326918) in Huizhou Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3023326918
- Address
- (Building 3), Changbu Village, Xinwei, Huiyang District, Huizhou Guangdong, China, 516200
- Owner or operator
- Huizhou XINYI Technology Co., LTD (10087052)
- Roles
- Manufacturer
- First device listed
- January 5, 2023
- Registered through
- 2026
- Brand names listed
- Air compression leg massager YY-A01L, Anaconda Fightwear Air compression leg massager YY-A01L, Medisana Air compression leg massager YY-A01L, Overlapped Compression Therapy YY-A02-B
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 2, 2024 | K240981 | Air compression leg massager | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K221862 | YY-A02-B Overlapped Compression Therapy | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 2, 2024. 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.