Device Classification Name |
wheelchair, powered
|
510(k) Number |
K060531 |
Device Name |
QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS |
Applicant |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Applicant Contact |
JOSEPH OLSAVSKY |
Correspondent |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Correspondent Contact |
JOSEPH OLSAVSKY |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 02/28/2006 |
Decision Date | 03/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|