FDA 510(k)

Wearable Breast Pump (Model S10)

K-Number: K220309 · 2022-06-27

ApplicantShenzhen Lutejiacheng Technology Co., Ltd.

Decision Date2022-06-27

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Wearable Breast Pump (Model S10) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K220309. 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 (Model S10)?

Wearable Breast Pump (Model S10) is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. The 510(k) number is K220309.

When did Wearable Breast Pump (Model S10) receive FDA 510(k) clearance?

Wearable Breast Pump (Model S10) received FDA 510(k) clearance on 2022-06-27, under 510(k) number K220309.

Who is the listed applicant for Wearable Breast Pump (Model S10)?

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

What is the FDA product code for Wearable Breast Pump (Model S10)?

The FDA product code for Wearable Breast Pump (Model S10) is HGX.

Other records listing Shenzhen Lutejiacheng Technology Co., Ltd. as applicant

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.

K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)K223693Electric breast pump (model: M5)

Related Devices (Code: HGX)

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

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