510(k) K023521

EASY LIFE by Berkline Corp. — Product Code INO

K023521 is an FDA 510(k) premarket notification submitted by Berkline Corp. for the device "EASY LIFE". The FDA issued a decision of Substantially Equivalent on November 19, 2002. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2002
Date Received
October 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Positioning, Electric
Device Class
Class II
Regulation Number
890.3110
Review Panel
PM
Submission Type