Travel Pal (MM-111B) /Mega Motion

FDA 510(k) K060697 · Mega Motion, Inc.

Substantially Equivalent

510(k) numberK060697

Submission

Device name
Travel Pal (MM-111B) /Mega Motion
Applicant
Mega Motion, Inc.
Old Forge, PA, US
Received
March 16, 2006
Decision date
April 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 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 Travel Pal (MM-111B) /Mega Motion cleared by the FDA?

Travel Pal (MM-111B) /Mega Motion (K060697) received a 510(k) decision of Substantially Equivalent on April 11, 2006, 26 days after the submission was received.

What is the product code of K060697?

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