510(k) K011751

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 by Merits Health Products., Inc. — Product Code INI

K011751 is an FDA 510(k) premarket notification submitted by Merits Health Products., Inc. for the device "TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3". The FDA issued a decision of Substantially Equivalent on Aug 6, 2001. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Merits Health Products., Inc. has 11 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 6, 2001
Date Received
Jun 6, 2001
Clearance Type
Special
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
510(k)

Source: FDA 510(k) database entry for K011751. Report a data issue: hello@regdatalab.com.