Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
Device Facts
| Record ID | K260538 |
|---|---|
| Device Name | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) |
| Applicant | Shenzhen Root Innovation Technology Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Jun 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.