Guangzhou Huakai Electronic Technology Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 5 device types, 1 clearance.
Guangzhou Huakai Electronic Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pad, Heating, Powered, Massager, Therapeutic, Electric and 3 other device types. Its earliest product listing with the FDA dates from 2015.
5device types registered with the FDA
1510(k) clearance
Registration
| Registered name | GUANGZHOU HUAKAI ELECTRONIC TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012729332 |
| FEI number | 3012729332 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州华凯电子科技有限公司 |
|---|---|
| Unified social credit code | 914401016935746125 |
| Source | provincial manufacturer licence lists |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | 4th Floor, Building 8, Bigang Ind Zone |
| Postal code | 510730 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | 2017 | 72 | |
| Massager, Therapeutic, Electric | Class 1 | HK-803, HK-805D, HK-805A, 807D, 803B, HK-710A, HK-710B, HK-710C, HK-710D, HK-801A, HK-801B, HK-801M, HK-712, Foot Massager, Huakai Foot Massager, HK-805H, HK-802H, HK-803A, HK-805B, HK-807, HK-818, HK-809, HK-802FS, HK-805C,, HK-807D, HK-802Pro, HK-712P, HK-730 | 2015 | 437 |
| Pad, Heating, Powered | Class 2 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | 2022 | 144 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | 2022 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) | 2022 | 57 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221251 | 2022-07-29 | NUH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Hydrogen water generators, Hydrogen inhalation machines, Ionic detox foot spa, Foot massagers, Air compression leg massagers |
|---|---|
| Certifications | CE, FDA |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.