Wearable Breast Pump (Model:YD-1193, YD-1195, YD-1196, YD-1198, YD-1199 +1 more…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222782

Identifiers

510(k) Number: K222782 FDA 510(k)
FDA Product Code: HGX FDA 510(k)
Models / Variants: Wearable Breast Pump (Model:YD-1193, YD-1195, YD-1196, YD-1198, YD-1199 FDA 510(k)
YD-1193S, YD-1195S, YD-1196S, YD-1198S, YD-1199S) 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)

Wearable Breast Pump (Model:YD-1193, YD-1195, YD-1196, YD-1198, YD-1199 +1 more… by Zhejiang Carebao Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)…

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	K222782	Class II	Active

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Manufacturer

Manufacturer: Zhejiang Carebao Co., Ltd.

Sources (1)

FDA 510(k) K222782 24 fields · synced Jun 19, 2026