Model: W3901
DI: 06978949462149
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
33962079-0f57-489f-a503-c1e17d26f54f
Distribution Status:
In Commercial Distribution
DUNS Number:
544392592
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06978949462149
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45684
Name: Assistive scooter, electric-motor-driven
Definition:
A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.
FDA Product Codes
INI
Vehicle, Motorized 3-Wheeled
Premarket Submissions
Submission Number:
K240990
Supplement Number:
000