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FDA 510(k)

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

K-Number: K193449 · 2020-09-11

ApplicantGuangdong Horigen Mother & Baby Products Co., Ltd.
Decision Date2020-09-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is a medical device manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2020-09-11 under approval number K193449. 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 KP033_01), Electric Double Breast Pump (model KP053_01)?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K193449.

When was Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) approved by the FDA?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) received FDA 510(k) clearance on 2020-09-11, under approval number K193449.

What company makes Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd..

What is the FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

The FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) 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 NCT05301959 Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT07535593 Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness NOT_YET_RECRUITING 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 Guangdong Horigen Mother & Baby Products Co., Ltd.

K162747Proture Double Electric Breast Pump K182413Electric Breast Pump K201152Electric Breast Pump K201974Single-use medical face mask K212564Electric Breast Pump

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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