DALTON SCOOTER SC-42E

GUDID 00815027012543

MOBILITY SCOOTER, ELECTRIC, 4 WHEELS, WITH CHARGER, BATTERY, FRONT BUMPERWT. LIMIT 265 lbs.

DALTON MEDICAL CORPORATION

Assistive scooter, electric-motor-driven

• Primary Device ID: 00815027012543
• NIH Device Record Key: eeade076-c168-4070-a257-75220089bc12
• Commercial Distribution Discontinuation: 2024-02-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DALTON SCOOTER
• Version Model Number: SC-42E
• Catalog Number: SC-42E
• Company DUNS: 874709348
• Company Name: DALTON MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815027012543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231472

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [DALTON SCOOTER]

• 00815027011614: ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 300 LBS.
• 00815027011607: ELECTRIC SCOOTER, 4 WHEEL, BLUE, WT. LIMIT 300 LBS.
• 00815027011591: ELECTRIC SCOOTER, 3 WHEEL, RED, WT. LIMIT 400 LBS.
• 00815027011584: ELECTRIC SCOOTER, 3 WHEEL, BLUE, WT. LIMIT 400 LBS.
• 00815027011577: ELECTRIC SCOOTER, 3 WHEEL, BLUE, WT. LIMIT 300 LBS.
• 00815027011560: ELECTRIC SCOOTER, 3 WHEEL, RED, WT. LIMIT 300 LBS.
• 00815027011553: ELECTRIC SCOOTER, 4 WHEEL, BLUE, WT. LIMIT 250 LBS.
• 00815027011546: ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 250 LBS.
• 00815027011430: ELECTRIC SCOOTER, 4 WHEEL, RED, WT. LIMIT 400 LBS.
• 00815027011423: ELECTRIC SCOOTER, 4 WHEEL, BLUE, WT. LIMIT 400 LBS.
• 00815027012543: MOBILITY SCOOTER, ELECTRIC, 4 WHEELS, WITH CHARGER, BATTERY, FRONT BUMPERWT. LIMIT 265 lbs.