eufy Wearable Breast Pump S1 (T8D02) Model T8D02 +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250152

Identifiers

510(k) Number: K250152 FDA 510(k)
FDA Product Code: HGX FDA 510(k)
Models / Variants: eufy Wearable Breast Pump S1 (T8D02) Model T8D02 FDA 510(k)
eufy Wearable Breast Pump E10 (T8D03) Model T8D03 FDA 510(k)
eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04 FDA 510(k)
eufy Wearable Breast Pump E20 (T6060) Model T6060 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.5160 FDA 510(k)
Regulation Number: 884.5160 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

eufy Wearable Breast Pump S1 (T8D02) Model T8D02 +3 more models by Shenzhen TPH Technology Co., Ltd — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K250152	Class II	Active

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Manufacturer

Manufacturer: Shenzhen TPH Technology Co., Ltd
FDA Applicant: Shenzhen TPH Technology Co., Ltd.

Sources (1)

FDA 510(k) K250152 24 fields · synced Jun 19, 2026