The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for Electric Breast Pump.
| Device ID | K172989 |
| 510k Number | K172989 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Contact | Ren Yunhua |
| Correspondent | Ren Yunhua Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-20 |
| Summary: | summary |