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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) 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. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250843.

When did Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

The FDA 510(k) record lists Shenzhen TPH Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shenzhen TPH Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)K261199Wearable Breast Pump (Model S32A)K260864Mother's Nature W1 Warming Wearable Breast PumpK254244Wearable Breast Pump (Model S39)K260033Wearable Breast Pump (Model S21A)K252422Wearable Breast Pump (Model W2)

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Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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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