510(k) clearance
Wearable Breast Pump (Model S36)
- 510(k) number
- K254203
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Decision date
- Sep 17, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HGX
- Device type
- Pump, Breast, Powered
- Device class
- Class II
- Regulation
- 21 CFR 884.5160
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN