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510(k) K072475

BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) by Etac Sverige AB — Product Code IPL

K072475 is an FDA 510(k) premarket notification submitted by Etac Sverige AB for the device "BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)". The FDA issued a decision of Substantially Equivalent on December 21, 2007. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2007
Date Received
September 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

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FDA data resources