FDA 510(k)

Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )

Numéro K : K260538 · 2026-06-17

DemandeurShenzhen Root Innovation Technology Co., Ltd.

Date de décision2026-06-17

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) 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 2026-06-17 under 510(k) number K260538. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )?

Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K260538.

When did Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) receive FDA 510(k) clearance?

Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260538.

Who is the listed applicant for Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )?

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 (BP420, BP420-A, BP420-B, BP420-C, BP420-D )?

The FDA product code for Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) is HGX.

Essais cliniques associés

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Autres dossiers indiquant Shenzhen Root Innovation Technology Co., Ltd. en tant que demandeur

K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-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)K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

Voir tous les 13 dispositifs →

Dispositifs connexes (Code : HGX)

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Source officielle

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