510(k) K183692

Avid IF2 by Vision Quest Industries Inc./Dba VQ Orthocare — Product Code LIH

K183692 is an FDA 510(k) premarket notification submitted by Vision Quest Industries Inc./Dba VQ Orthocare for the device "Avid IF2". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Vision Quest Industries Inc./Dba VQ Orthocare has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2019
Date Received
December 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type