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FDA 510(k)

Wearable breast pump

K-Number: K221598 · 2022-12-09

ApplicantMayborn (Uk) Limited
Decision Date2022-12-09
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Mayborn (Uk) Limited. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K221598. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wearable breast pump?

Wearable breast pump is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Mayborn (Uk) Limited. The 510(k) number is K221598.

When did Wearable breast pump receive FDA 510(k) clearance?

Wearable breast pump received FDA 510(k) clearance on 2022-12-09, under 510(k) number K221598.

Who is the listed applicant for Wearable breast pump?

The FDA 510(k) record lists Mayborn (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable breast pump?

The FDA product code for Wearable breast pump is HGX.

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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