510(k) K834498

TRAIL CHAIR by Winchester Industries, Inc. — Product Code IQC

K834498 is an FDA 510(k) premarket notification submitted by Winchester Industries, Inc. for the device "TRAIL CHAIR". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Special Grade
Device Class
Class II
Regulation Number
890.3880
Review Panel
PM
Submission Type