Shenzhen Root Innovation Te... — FDA 510(k) Submissions

Shenzhen Root Innovation Technology Co., Ltd. — FDA 510(k) Submissions

Shenzhen Root Innovation Technology Co., Ltd. has submitted 6 FDA 510(k) premarket notifications since 2024, of which 6 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.

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)

K253934 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Mar 2026 90d

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

K253283 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Oct 2025 30d

Momcozy Wearable Breast Pump (BP223)

K251394 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Sep 2025 126d

Momcozy Wearable Breast Pump (BP311)

K241680 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Dec 2024 192d

Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)

K243629 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Dec 2024 25d

Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

K233880 · HGX Pump, Breast, Powered · Obstetrics & Gynecology

Mar 2024 89d

Shenzhen Root Innovation Technology Co., Ltd.

Shenzhen Root Innovation Technology Co., Ltd. — FDA 510(k) Submissions

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