Data / Medical devices / China / Xiamen Healthpal Electronic Co,.ltd.
Xiamen Healthpal Electronic Co,.ltd.: FDA-registered device maker in Xiamen Fujian, China, 1 510(k) clearance
Xiamen Healthpal Electronic Co,.ltd. is registered with the FDA (registration 3014977697) in Xiamen Fujian, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014977697
- Address
- 2F-4F-5F, No.1019-2, Wanjiachun Road Torch High-Technic Zone (Xiang'an), Industrial Park, Xiamen Fujian, China, 361100
- Owner or operator
- Xiamen Healthpal Electronic Co,.Ltd. (10060779)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 22, 2019
- Registered through
- 2026
- Brand names listed
- Air compression leg massager (FE-7203, FE-7203A, FE-7203B, FE-7202, FE-7202A, FE-7202B; Air compression leg massager (FE-7204B);, Air compression leg massager (FE-7204B), Air compression leg massager (FE-7204B); Air compression leg massager (FE-7301); Air compression leg massager (WELOV L500, WELOV L700);, Air compression leg massager (FE-7208MD); FE-7216, AJLELM24, FE-7211, FE-7621, AJHDM22, AJACLRSP-L10, AJACLRS-L9; FE-7228;, Air compression massager (AJFLM22, FE-7109, AJSKM23, AJCACCM23, AJCLM23, AJFLWM23), Air compression massager (FE-7205, AJACCM23, FE-7213, AJLM22, FE-7214); B0DJW1J2ZN G1-DW9H-5IJO;, Deep4s FE-5868; Dextra FE-0152; Electric; Eye massage; Foot Massage FE-5311, AJFTM22, FE-0159, FE-0184, FE-4120, FE-7002, FE-4506, FE-5320SU, FE-0155, FE-4606, FE-5859, FE-5862, FE-4002-1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 3, 2022 | K211850 | Air Compression Leg Massager (model: FE-7204B) | IRP | Substantially Equivalent | Xiamen Healthpal Electronic Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Powered Inflatable Tube
- All makers of Massager, Therapeutic, Electric
Updated March 3, 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.