MEGA 3

Vehicle, Motorized 3-wheeled

MEGA MOTION, INC.

The following data is part of a premarket notification filed by Mega Motion, Inc. with the FDA for Mega 3.

Pre-market Notification Details

• Device ID: K982145
• 510k Number: K982145
• Device Name: MEGA 3
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: MEGA MOTION, INC. P.O. BOX 3744 Scranton, PA 18505
• Contact: Paul Gronka
• Correspondent: Paul Gronka; MEGA MOTION, INC. P.O. BOX 3744 Scranton, PA 18505
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-17
• Decision Date: 1999-04-14
• Summary: summary