The following data is part of a premarket notification filed by Future Mobility Healthcare Inc. with the FDA for Orion Ii (heavy Duty 350 Lbs And 500 Lbs).
| Device ID | K101277 |
| 510k Number | K101277 |
| Device Name: | ORION II (HEAVY DUTY 350 LBS AND 500 LBS) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-06-04 |
| Summary: | summary |