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510(k) K142162

MERITS TRANSFORMER POWER SCOOTER, S941 by Merits Health Products Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2015
Date Received
August 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vehicle, Motorized 3-Wheeled
Device Class
Class II
Regulation Number
890.3800
Review Panel
PM
Submission Type

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