Data / Medical devices / China / Xiamen High Top Electronic Technology Co.,ltd.
Xiamen High Top Electronic Technology Co.,ltd.: FDA-registered device maker in Xiamen City Fujian, China, 1 510(k) clearance
Xiamen High Top Electronic Technology Co.,ltd. is registered with the FDA (registration 3012365608) in Xiamen City Fujian, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012365608
- Address
- F2-5, No.118 Siming Garden, Tong'an Industrial Park, Xiamen City Fujian, China, 361100
- Owner or operator
- Xiamen High top Electronic Technology Co.,Ltd. (10050927)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- January 18, 2016
- Registered through
- 2026
- Brand names listed
- Air Compression Leg Massager HY-1117A, Leg Massager R-F001, Leg Massager RF-ALM070, Leg Massager RF-ALM071, Massage Cushion HY-6122, Massager RE-XPRESS, Nasal Aspirator, Model: HY-7035
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 18, 2022 | K212713 | Air compression leg massager HY-1117A | IRP | Substantially Equivalent | Xiamen High Top Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Massager, Powered Inflatable Tube
- All makers of Massager, Therapeutic, Electric
Updated January 18, 2022. 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.