The following data is part of a premarket notification filed by Future Mobility Healthcare Inc. with the FDA for Super Chair For Kids By Orion.
Device ID | K103073 |
510k Number | K103073 |
Device Name: | SUPER CHAIR FOR KIDS BY ORION |
Classification | Wheelchair, Mechanical |
Applicant | FUTURE MOBILITY HEALTHCARE INC. 3223 ORLANDO DRIVE Mississauga, CA L4v 1c5 |
Contact | Abdulsamad Panchbhaya |
Correspondent | Abdulsamad Panchbhaya FUTURE MOBILITY HEALTHCARE INC. 3223 ORLANDO DRIVE Mississauga, CA L4v 1c5 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-18 |
Decision Date | 2011-01-03 |
Summary: | summary |