The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Quickie & Zippie Series.
Device ID | K123975 |
510k Number | K123975 |
Device Name: | QUICKIE & ZIPPIE SERIES |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL 2842 BUSINESS PARK AVE. Fresno, CA 93727 -1328 |
Contact | Laurie Roberts |
Correspondent | Laurie Roberts SUNRISE MEDICAL 2842 BUSINESS PARK AVE. Fresno, CA 93727 -1328 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-26 |
Decision Date | 2013-08-16 |