FREERIDER FR1, models FR1-13, FR1-15, FR1-17

FDA 510(k) K133187 · Freerider Corp

Substantially Equivalent

510(k) numberK133187

Submission

Device name
FREERIDER FR1, models FR1-13, FR1-15, FR1-17
Applicant
Freerider Corp
Rancho Cucamonga, CA, US
Received
October 17, 2013
Decision date
January 8, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 FREERIDER FR1, models FR1-13, FR1-15, FR1-17 cleared by the FDA?

FREERIDER FR1, models FR1-13, FR1-15, FR1-17 (K133187) received a 510(k) decision of Substantially Equivalent on January 8, 2015, 448 days after the submission was received.

What is the product code of K133187?

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