BASEN Wearable Breast Pump (Model: YM-801 +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231969

by Dongguanshi Yiyingmei Technology Co., Ltd.

Identifiers

510(k) Number: K231969 FDA 510(k)
FDA Product Code: HGX FDA 510(k)
Models / Variants: Model: YM-801 FDA 510(k)
YM-803 FDA 510(k)
YM-805 FDA 510(k)
YM-806 FDA 510(k)
YM-808 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)

BASEN Wearable Breast Pump (Model: YM-801 +4 more) by Dongguanshi Yiyingmei Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 5 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	K231969	Class II	Active

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Manufacturer

Manufacturer: Dongguanshi Yiyingmei Technology Co., Ltd.

Sources (1)

FDA 510(k) K231969 24 fields · synced Jun 18, 2026