510(k) K242760

WHILL Model R by Whill, Inc. — Product Code INI

K242760 is an FDA 510(k) premarket notification submitted by Whill, Inc. for the device "WHILL Model R". The FDA issued a decision of Substantially Equivalent on January 6, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Whill, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2025
Date Received
September 12, 2024
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