FDA 510(k) Application Details - K250046

Device Classification Name	Massager, Powered Inflatable Tube   More FDA Info for this Device
510(K) Number	K250046
Device Name	Massager, Powered Inflatable Tube
Applicant	Shenzhen Urion Technology Co., Ltd. Fl 4-6th of Bldg D, Jiale Science & Technology Indust Zn,No3 Chuang Wei Rd.,Heshuikou Community,MaTian St,GuangMing NewDi Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Janice Ou Other 510(k) Applications for this Contact
Regulation Number	890.5650   More FDA Info for this Regulation Number
Classification Product Code	IRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	04/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review