The following data is part of a premarket notification filed by Shenzhen Tph Technology Co., Ltd. with the FDA for Wearable Breast Pump (model S12).
| Device ID | K212180 |
| 510k Number | K212180 |
| Device Name: | Wearable Breast Pump (Model S12) |
| Classification | Pump, Breast, Powered |
| Applicant | Shenzhen TPH Technology Co., Ltd. Bulan Road, Nanwan Community, Longgang District Shenzhen, CN 518100 |
| Contact | Peter Chen |
| Correspondent | Peter Chen Shenzhen TPH Technology Co., Ltd. Bulan Road, Nanwan Community, Longgang District Shenzhen, CN 518100 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973493590850 | K212180 | 000 |
| 06973493599860 | K212180 | 000 |
| 06973493597316 | K212180 | 000 |
| 06973493590317 | K212180 | 000 |
| 06973493594179 | K212180 | 000 |
| 06973493599198 | K212180 | 000 |
| 06973493595794 | K212180 | 000 |
| 36973493598031 | K212180 | 000 |