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FDA 510(k)

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

K-Number: K250843 · 2025-07-31

ApplicantShenzhen TPH Technology Co., Ltd.
Decision Date2025-07-31
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is a medical device manufactured by Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-31 under approval number K250843. 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 FS12A); Wearable Breast Pump (Model FS12B)?

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250843.

When was Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) approved by the FDA?

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) received FDA 510(k) clearance on 2025-07-31, under approval number K250843.

What company makes Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is manufactured by Shenzhen TPH Technology Co., Ltd..

What is the FDA product code for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

The FDA product code for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is HGX.

Related Clinical Trials

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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 TPH Technology Co., Ltd.

K220596Wearable Breast Pump (Model S9) K212180Wearable Breast Pump (Model S12) K223886Wearable Breast Pump (Model S18) K222045Wearable Breast Pump (Model S1DW) K240536Wearable Breast Pump (Model S32) K251754Wearable Breast Pump (Model S33)

View all 19 devices →

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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