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 |