Data / Medical devices / China / Guangzhou Huakai Electronic Technology Co., Ltd.
Guangzhou Huakai Electronic Technology Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Guangzhou Huakai Electronic Technology Co., Ltd. is registered with the FDA (registration 3012729332) in Guangzhou Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012729332
- Address
- 4th Floor, Building 8, Bigang Ind Zone Nangang,Huangpu District, Guangzhou Guangdong, China, 510730
- Owner or operator
- Guangzhou HuaKai Electronic Technology Co., Ltd. (10050595)
- Roles
- Manufacturer
- First device listed
- December 7, 2015
- Registered through
- 2026
- Brand names listed
- Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C), Foot Massager, Huakai Foot Massager, HK-805H, HK-802H, HK-803A, HK-805B, HK-807, HK-818, HK-809, HK-802FS, HK-805C,, HK-803, HK-805D, HK-805A, 807D, 803B, HK-710A, HK-710B, HK-710C, HK-710D, HK-801A, HK-801B, HK-801M, HK-712, HK-807D, HK-802Pro, HK-712P, HK-730
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 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 |
|---|---|---|---|---|---|---|
| July 29, 2022 | K221251 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | NUH | Substantially Equivalent | Guangzhou Huakai Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Pad, Heating, Powered
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Massager, Therapeutic, Electric
Updated July 29, 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.