510(k) K253149— Motion InBra (YM-8801) wearable breast pump

Substantially Equivalent

Medela, LLC

Clearance details

Applicant: Medela, LLC
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-09-25
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.