The following data is part of a premarket notification filed by Columbia Medical Manufacturing, Llc with the FDA for Innova Wheelchair.
| Device ID | K110788 |
| 510k Number | K110788 |
| Device Name: | INNOVA WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | COLUMBIA MEDICAL MANUFACTURING, LLC 11724 WILLAKE STREET Santa Fe Springs, CA 90670 |
| Contact | Susan Johnson |
| Correspondent | Susan Johnson COLUMBIA MEDICAL MANUFACTURING, LLC 11724 WILLAKE STREET Santa Fe Springs, CA 90670 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822383938813 | K110788 | 000 |
| 00822383936024 | K110788 | 000 |
| 00822383936017 | K110788 | 000 |