Dalton Scooter

FDA UDI

Class II (US FDA UDI)

by Dalton Medical Corp.

Identity

Trade Name: DALTON SCOOTER FDA UDI
Generic Name: Assistive scooter, electric-motor-driven FDA UDI
Device Name: MOBILITY SCOOTER, ELECTRIC, 4 WHEELS, WITH CHARGER, BATTERY, FRONT BUMPERWT. LIMIT 265 lbs. FDA UDI
Model / Reference: SC-42E FDA UDI
Description: MOBILITY SCOOTER, ELECTRIC, 4 WHEELS, WITH CHARGER, BATTERY, FRONT BUMPERWT. LIMIT 265 lbs. FDA UDI

Identifiers

Catalog Number: SC-42E FDA UDI
Primary DI / UDI-DI: 00815027012543 FDA UDI
510(k) Number: K231472 FDA UDI
FDA Product Code: INI FDA UDI
GMDN Term: Assistive scooter, electric-motor-driven FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Assistive scooter, electric-motor-driven

Dalton Scooter by Dalton Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FREERIDER — Freerider Corporation · Class II

Cleared under the same submission

K231472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dalton Medical Corp.

Sources (1)

FDA UDI eeade076-c168-4070-a257-75220089bc12 36 fields · synced May 30, 2026