The following data is part of a premarket notification filed by Colours 'n Motion with the FDA for Mechanical Wheelchair- Lil Dipper.
Device ID | K945153 |
510k Number | K945153 |
Device Name: | MECHANICAL WHEELCHAIR- LIL DIPPER |
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 | 1994-10-20 |
Decision Date | 1995-05-12 |