510(k) K142162

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

K142162 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "MERITS TRANSFORMER POWER SCOOTER, S941". The FDA issued a decision of Substantially Equivalent on May 1, 2015. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.

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