510(k) K172882

UINCARE HOME by Uincare Corp. — Product Code LXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2018
Date Received
September 21, 2017
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