The following data is part of a premarket notification filed by Guangzhou Hua Kai Electronic Technology Co., Ltd. with the FDA for Ems Foot Stimulator (model: Hk701, Hk701a, Hk701b, Hk701c).
| Device ID | K221251 |
| 510k Number | K221251 |
| Device Name: | Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Guangzhou Hua Kai Electronic Technology Co., Ltd. 4th Floor, Building 8, No.39 Bi Gang Road, Dongqu Street, Huangpu District Guangzhou, CN 510730 |
| Contact | Cao Ke |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | NUH |
| Subsequent Product Code | IRT |
| Subsequent Product Code | NGX |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974241370540 | K221251 | 000 |
| 06974241370441 | K221251 | 000 |
| 06974241370458 | K221251 | 000 |
| 06974241370465 | K221251 | 000 |
| 06974241370472 | K221251 | 000 |
| 06974241370489 | K221251 | 000 |
| 06974241370496 | K221251 | 000 |
| 06974241370502 | K221251 | 000 |
| 06974241370519 | K221251 | 000 |
| 06974241370526 | K221251 | 000 |
| 06974241370533 | K221251 | 000 |
| 06974241370366 | K221251 | 000 |