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FDA 510(k)

Wearable breast pump (model S12A)

K-Number: K243508 · 2025-04-21

ApplicantShenzhen TPH Technology Co., Ltd.
Decision Date2025-04-21
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable breast pump (model S12A) is a medical device manufactured by Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under approval number K243508. 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 S12A)?

Wearable breast pump (model S12A) is a medical device that received FDA 510(k) clearance on 2025-04-21. It is manufactured by Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K243508.

When was Wearable breast pump (model S12A) approved by the FDA?

Wearable breast pump (model S12A) received FDA 510(k) clearance on 2025-04-21, under approval number K243508.

What company makes Wearable breast pump (model S12A)?

Wearable breast pump (model S12A) is manufactured by Shenzhen TPH Technology Co., Ltd..

What is the FDA product code for Wearable breast pump (model S12A)?

The FDA product code for Wearable breast pump (model S12A) 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 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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