K260033

Substantially Equivalent

Wearable Breast Pump (Model S21A)

The Wearable Breast Pump (Model S21A) is another wearable in-bra breast pump. Product code HGX, same category as Momcozy and Medela. Generic product name and single-SKU filing suggest this is a white-label or OEM product rather than a direct-to-consumer branded line.

Obstetrics/Gynecology panel, Traditional 510(k). Chinese-manufactured wearable pumps make up a substantial share of HGX clearances; many are OEM products that are rebranded by US and European distributors for retail sale.

Shenzhen TPH Technology files from Shenzhen. Three-month review clock — on the faster end for HGX.

Applicant: Shenzhen TPH Technology Co., Ltd.
Product code: HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2026-01-06
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.