Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K123975 |
Device Name |
QUICKIE & ZIPPIE SERIES |
Applicant |
SUNRISE MEDICAL |
2842 BUSINESS PARK AVE. |
FRESNO,
CA
93727 -1328
|
|
Applicant Contact |
LAURIE ROBERTS |
Correspondent |
SUNRISE MEDICAL |
2842 BUSINESS PARK AVE. |
FRESNO,
CA
93727 -1328
|
|
Correspondent Contact |
LAURIE ROBERTS |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 12/26/2012 |
Decision Date | 08/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|