510(k) K840629

WHEELCHAIR ACCESSORIES by Poirier S.A. — Product Code KNN

K840629 is an FDA 510(k) premarket notification submitted by Poirier S.A. for the device "WHEELCHAIR ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Poirier S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
January 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type