K253072
- 510(k) number
- K253072
- Device name
- Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
- Applicant
- Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2025-12-23
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253072.pdf
Official FDA record: K253072
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.