The following data is part of a premarket notification filed by Future Mobility Healthcare Inc. with the FDA for Galaxy Lite.
| Device ID | K102031 |
| 510k Number | K102031 |
| Device Name: | GALAXY LITE |
| Classification | Wheelchair, Mechanical |
| Applicant | FUTURE MOBILITY HEALTHCARE INC. 3223 ORLANDO DRIVE Mississauga, Ontario, CA L4v 1c5 |
| Contact | Abdulsamad Panchbhaya |
| Correspondent | Abdulsamad Panchbhaya FUTURE MOBILITY HEALTHCARE INC. 3223 ORLANDO DRIVE Mississauga, Ontario, 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 | 2010-07-19 |
| Decision Date | 2010-10-20 |
| Summary: | summary |