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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 a medical device manufactured by Shenzhen Lutejiacheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-27 under approval 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. It is manufactured by Shenzhen Lutejiacheng Technology Co., Ltd.. The 510(k) number is K220309.

When was Wearable Breast Pump (Model S10) approved by the FDA?

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

What company makes Wearable Breast Pump (Model S10)?

Wearable Breast Pump (Model S10) is manufactured by Shenzhen Lutejiacheng Technology Co., Ltd..

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

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

Related Clinical Trials

NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07277738 Precision Supplemental Imaging in Women With Dense Breasts NOT_YET_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT06865755 Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication NOT_YET_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.

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

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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