510(k) K143034

Jintronix by Jintronix, Inc. — Product Code LXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2015
Date Received
October 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interactive Rehabilitation Exercise Devices
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type