510(k) K131909

DALTON LIFT CHAIR by Dalton Instrument Corp. — Product Code INO

K131909 is an FDA 510(k) premarket notification submitted by Dalton Instrument Corp. for the device "DALTON LIFT CHAIR". The FDA issued a decision of Substantially Equivalent on February 24, 2014. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Dalton Instrument Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2014
Date Received
June 26, 2013
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