The following data is part of a premarket notification filed by Future Mobility Healthcare Inc. with the FDA for Future Mobility Healthcare Inc. Orion Ii Wheelchair And Stellato Mechanical Wheelchair.
| Device ID | K061010 |
| 510k Number | K061010 |
| Device Name: | FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | FUTURE MOBILITY HEALTHCARE INC. 2775 SLOUGH STR Mississauga, On, CA L4t 1g2 |
| Contact | William Salter |
| Correspondent | William Salter FUTURE MOBILITY HEALTHCARE INC. 2775 SLOUGH STR Mississauga, On, CA L4t 1g2 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-12 |
| Decision Date | 2006-05-23 |
| Summary: | summary |