FDA 510(k)

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

K-Nummer: K253934 · 2026-03-09

AntragstellerShenzhen Root Innovation Technology Co., Ltd.

Entscheidungsdatum2026-03-09

ProduktcodeHGX

BeratungsausschussOB

EntscheidungSubstantially Equivalent

Produktübersicht

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K253934. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)?

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253934.

When did Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) receive FDA 510(k) clearance?

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) received FDA 510(k) clearance on 2026-03-09, under 510(k) number K253934.

Who is the listed applicant for Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)?

The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)?

The FDA product code for Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) is HGX.

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Weitere Einträge mit Shenzhen Root Innovation Technology Co., Ltd. als Antragsteller

K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )K253629Momcozy Nasal Aspirator (BN007)K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)

Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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