Model: FDB01
DI: 06973175531348
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
238ed86f-8df9-49ce-8eb3-5a0270fe09d7
Distribution Status:
In Commercial Distribution
DUNS Number:
554547530
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06973175531348
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:
K201196
Supplement Number:
000