The following data is part of a premarket notification filed by Free Wheelchair Mission with the FDA for Gen_2 And Gen_3 Mechanical Wheelchairs.
| Device ID | K170701 |
| 510k Number | K170701 |
| Device Name: | GEN_2 And GEN_3 Mechanical Wheelchairs |
| Classification | Wheelchair, Mechanical |
| Applicant | Free Wheelchair Mission 15279 Alton Parkway Suite 300 Irvine, CA 92618 |
| Contact | Don Schoendorfer |
| Correspondent | Sharon Rockwell Sharon Rockwell, Consultant 5582 Chalon Road Yorba Linda, CA 92886 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-08 |
| Decision Date | 2017-03-24 |
| Summary: | summary |