FDA 510(k)

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

Numéro K : K250843 · 2025-07-31

DemandeurShenzhen TPH Technology Co., Ltd.

Date de décision2025-07-31

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : HGX)

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Source officielle

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