meddevicedb.com FDA Device Reference

Wearable Breast Pump (Model S12)

K212180 Class II Traditional
Decision Date
2022-02-11
Sponsor / Applicant
Shenzhen TPH Technology Co., Ltd.

Technical Specification

510(k) Submission ID K212180
Product Code HGX
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5160
Decision Date 2022-02-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Wearable Breast Pump (Model S12) received FDA 510(k) clearance under submission number K212180, sponsored by Shenzhen TPH Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2022-02-11.

Classification & Regulation

This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.