The following data is part of a premarket notification filed by Sunrise Medical (us) Llc with the FDA for Breezy Elegance.
Device ID | K133855 |
510k Number | K133855 |
Device Name: | BREEZY ELEGANCE |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL (US) LLC 2842 BUSINESS PARK AVE Fresno, CA 93727 |
Contact | Laurie H Roberts |
Correspondent | Laurie H Roberts SUNRISE MEDICAL (US) LLC 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 | 2013-12-19 |
Decision Date | 2014-01-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BREEZY ELEGANCE 86198384 4736411 Live/Registered |
Sunrise Medical (US) LLC 2014-02-19 |