Model Segaego 4D Scooter

FDA 510(k) K071282 · Dalton Medical Corp.

Substantially Equivalent

510(k) numberK071282

Submission

Device name
Model Segaego 4D Scooter
Applicant
Dalton Medical Corp.
Carrollton, TX, US
Received
May 7, 2007
Decision date
July 27, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
INI – Vehicle, Motorized 3-Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3800
Specialty
Physical Medicine

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Questions and answers

When was Model Segaego 4D Scooter cleared by the FDA?

Model Segaego 4D Scooter (K071282) received a 510(k) decision of Substantially Equivalent on July 27, 2007, 81 days after the submission was received.

What is the product code of K071282?

The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.