Wearable Breast Pump (Model S21A)— 510(k) K260033
Substantially EquivalentShenzhen TPH Technology Co., Ltd.
FDA 510(k) clearance K260033 for Wearable Breast Pump (Model S21A), Substantially Equivalent on 2026-04-08. Applicant: Shenzhen TPH Technology Co., Ltd..
Summary
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.
Clearance details
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Product code
- 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.