TT Electric Breast Pump, TT Double Electric Breast Pump— 510(k) K202802

Substantially Equivalent

Wuxi Xinzhongrui Baby Supplies Co., Ltd.

FDA 510(k) clearance K202802 for TT Electric Breast Pump, TT Double Electric Breast Pump, Substantially Equivalent on 2021-08-26. Applicant: Wuxi Xinzhongrui Baby Supplies Co., Ltd..

Clearance details

Applicant: Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2020-09-23
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

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.