510(k) K242140

Air Compression Leg Massager (K-705) by Jiale Health Technology Shenzhen Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2025
Date Received
July 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type