The following data is part of a premarket notification filed by Colours 'n Motion with the FDA for Mechanical Wheelchair.
| Device ID | K984354 |
| 510k Number | K984354 |
| Device Name: | MECHANICAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | COLOURS 'N MOTION 1591 SOUTH SINCLAIR ST. Anaheim, CA 92806 |
| Contact | John G Box |
| Correspondent | John G Box COLOURS 'N MOTION 1591 SOUTH SINCLAIR ST. Anaheim, CA 92806 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-01-28 |