Medical Device Manufacturer · CN , Shenzhen

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

1 submissions · 1 cleared · Since 2025

Total

Cleared

Denied

Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. — FDA 510(k) Submissions

Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Breast, Powered . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

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)

K253072 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Dec 2025 91d

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

Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. — FDA 510(k) Submissions

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