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FDA 510(k)

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)

K-Number: K252192 · 2025-08-13

ApplicantHuizhou Lvb Maternal and Infant Supplies Co., Ltd.
Decision Date2025-08-13
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is a medical device manufactured by Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under approval number K252192. 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 (P9, P10, P16, P20, P21, P22, P23, P25)?

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K252192.

When was Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) approved by the FDA?

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) received FDA 510(k) clearance on 2025-08-13, under approval number K252192.

What company makes Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)?

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is manufactured by Huizhou Lvb Maternal and Infant Supplies Co., Ltd..

What is the FDA product code for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)?

The FDA product code for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) is HGX.

Related Clinical Trials

NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT06865755 Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication NOT_YET_RECRUITING

Other Devices by Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

K230102Smart double sides wearable breast pump, Electric bilateral breast pump K241004Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

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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