510(k) K250365

Motif Aura Glow breast pump (Model Motif Aura Glow) by Shenzhen TPH Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2025
Date Received
February 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type