Name: Predicase
Price: 199 USD

K-number	K253283
Device name	Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
Applicant	Shenzhen Root Innovation Technology Co., Ltd.
Product code	HGX
Device class	Class II
Decision date	Oct 29, 2025
Decision	Substantially Equivalent
Regulation	884.5160

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

Everything you need for a 510(k) submission. Nothing you don't.