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)— 510(k) K253072

Substantially Equivalent

Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.

FDA 510(k) clearance K253072 for 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), Substantially Equivalent on 2025-12-23. Applicant: Linhejiacheng (Shenzhen) E-Commerce Co., Ltd..

Clearance details

Applicant: Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-23
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.