The following data is part of a premarket notification filed by Sunrise Medical Quickie Designs, Inc. with the FDA for Quickie Carbon Wheelchair.
Device ID | K915533 |
510k Number | K915533 |
Device Name: | QUICKIE CARBON WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL QUICKIE DESIGNS, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Contact | Pat Spink |
Correspondent | Pat Spink SUNRISE MEDICAL QUICKIE DESIGNS, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-10 |
Decision Date | 1992-01-22 |