Paruu Wearable Breast pump (P16 +22 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253072

by Linhejiacheng (Shenzhen) E-commerce Co., Ltd.

Identifiers

510(k) Number: K253072 FDA 510(k)
FDA Product Code: HGX FDA 510(k)
Models / Variants: P16 FDA 510(k)EUDAMED
P16-A FDA 510(k)EUDAMED
P16-B FDA 510(k)EUDAMED
P16-C FDA 510(k)EUDAMED
P16-D FDA 510(k)EUDAMED
P20 FDA 510(k)EUDAMED
P9 FDA 510(k)EUDAMED
P10 FDA 510(k)EUDAMED
P10 PRO FDA 510(k)EUDAMED
P21 FDA 510(k)EUDAMED
P22 FDA 510(k)EUDAMED
P23 FDA 510(k)EUDAMED
P24 FDA 510(k)EUDAMED
P25 FDA 510(k)EUDAMED
P26 FDA 510(k)EUDAMED
P27 FDA 510(k)EUDAMED
P28 FDA 510(k)EUDAMED
P29 FDA 510(k)EUDAMED
P30 FDA 510(k)EUDAMED
P20-A FDA 510(k)EUDAMED
P20-B FDA 510(k)EUDAMED
P20-C FDA 510(k)EUDAMED
P20-D FDA 510(k)EUDAMED

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)

The Paruu Wearable Breast Pump is a powered, wearable device designed for breast milk expression. Classified as a Class II medical device, it is intended for manual-free milk extraction, allowing users to pump discreetly while engaged in daily activities. The device operates via battery power and is engineered to provide continuous, hands-free operation for convenience and comfort during use.

This wearable breast pump is supplied as a single-use or reusable device, depending on the model variant, and is intended for home or clinical use. It is not MRI-safe and must be stored according to manufacturer instructions to maintain functionality. The device holds FDA 510(k) clearance and MDR authorization, with multiple registration numbers listed under Chinese regulatory requirements. Each model variant (e.g., P16, P20) may have specific storage and usage guidelines as detailed in the accompanying instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K253072	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Linhejiacheng (Shenzhen) E-commerce Co., Ltd.

Sources (2)

FDA 510(k) K253072 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026