The following data is part of a premarket notification filed by Mega Motion, Inc. with the FDA for Travel Pal (mm-111b) /mega Motion.
Device ID | K060697 |
510k Number | K060697 |
Device Name: | TRAVEL PAL (MM-111B) /MEGA MOTION |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | MEGA MOTION, INC. 957 WOOD ST. Old Forge, PA 18518 |
Contact | Mark Calomino |
Correspondent | Mark Calomino MEGA MOTION, INC. 957 WOOD ST. Old Forge, PA 18518 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-16 |
Decision Date | 2006-04-11 |
Summary: | summary |