DALTON SCOOTER

Basic Information

• Brand Name: DALTON SCOOTER
• Primary DI: 00815027011577
• Version / Model: SC-S235BL
• Company Name: DALTON MEDICAL CORPORATION
• Labeler DUNS: 874709348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 924d0fe0-94db-4662-b14a-94465b87c98a

Device Description

ELECTRIC SCOOTER, 3 WHEEL, BLUE, WT. LIMIT 300 LBS.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	890.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45684	Assistive scooter, electric-motor-driven	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815027011577	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			OVERALL 23"W x 44"L, SEAT 17"W x 16"D.