The following data is part of a premarket notification filed by Free Wheelchair Mission with the FDA for Gen_2 Mechanical Wheelchair.
| Device ID | K113713 |
| 510k Number | K113713 |
| Device Name: | GEN_2 MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | FREE WHEELCHAIR MISSION 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell FREE WHEELCHAIR MISSION 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-05-07 |
| Summary: | summary |