K254258
Substantially EquivalentMomcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
The Momcozy Wearable Breast Pump covers a dozen SKU variants across the BP137 and BP141 product lines — in-bra style wearable pumps in the category Willow and Elvie opened up. Product code HGX covers powered breast pumps.
Obstetrics/Gynecology panel, Traditional 510(k). Large multi-SKU filings are common for wearable-pump manufacturers because size and fit variations typically require their own clearance, which inflates the SKU count on any given 510(k). Momcozy has become one of the higher-volume direct-to-consumer pump brands.
Shenzhen Root Innovation Technology files from Shenzhen. Three-and-a-half-month review clock — fast for a multi-SKU HGX filing, suggesting the predicate comparison landed cleanly.
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd.
- Product code
- HGX
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.