Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K011268 |
Device Name |
BREEZY WHEELCHAIR, MODEL 300 |
Applicant |
SUNRISE MEDICAL, INC. |
7477 EAST DRY CREEK PKWY. |
LONGMONT,
CO
80503
|
|
Applicant Contact |
JOHN GERHOLD |
Correspondent |
SUNRISE MEDICAL, INC. |
7477 EAST DRY CREEK PKWY. |
LONGMONT,
CO
80503
|
|
Correspondent Contact |
JOHN GERHOLD |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 04/26/2001 |
Decision Date | 05/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|