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510(k) K071761

LLOYD LINDEN, MODEL E04 by Lloyd Linden, Inc. — Product Code IPL

K071761 is an FDA 510(k) premarket notification submitted by Lloyd Linden, Inc. for the device "LLOYD LINDEN, MODEL E04". The FDA issued a decision of Substantially Equivalent on August 3, 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
August 3, 2007
Date Received
June 29, 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