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FDA 510(k)

Electric breast pump (model: M5)

K-Number: K223693 · 2023-03-09

ApplicantShenzhen Lutejiacheng Technology Co., Ltd.
Decision Date2023-03-09
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric breast pump (model: M5) is a medical device manufactured by Shenzhen Lutejiacheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-09 under approval number K223693. 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 Electric breast pump (model: M5)?

Electric breast pump (model: M5) is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by Shenzhen Lutejiacheng Technology Co., Ltd.. The 510(k) number is K223693.

When was Electric breast pump (model: M5) approved by the FDA?

Electric breast pump (model: M5) received FDA 510(k) clearance on 2023-03-09, under approval number K223693.

What company makes Electric breast pump (model: M5)?

Electric breast pump (model: M5) is manufactured by Shenzhen Lutejiacheng Technology Co., Ltd..

What is the FDA product code for Electric breast pump (model: M5)?

The FDA product code for Electric breast pump (model: M5) is HGX.

Related Clinical Trials

NCT07277738 Precision Supplemental Imaging in Women With Dense Breasts NOT_YET_RECRUITING NCT06235970 Cognitive Enhancement Through Model-based and Individualized Neurostimulation COMPLETED NCT05746325 Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer RECRUITING

Related PubMed Literature

PMID: 41779786 Stress-dependent growth in breast cancer arises from a mechano-osmotic coupling and cell-sizing checkpoint. Proceedings of the National Academy of Sciences of the United States of America (2026)

Other Devices by Shenzhen Lutejiacheng Technology Co., Ltd.

K220309Wearable Breast Pump (Model S10) K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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