Device Classification Name |
wheelchair, powered
|
510(k) Number |
K142457 |
Device Name |
Quickie, Zippie |
Applicant |
Sunrise Medical (US) LLC |
2842 Business Park Ave. |
Fresno,
CA
93727
|
|
Applicant Contact |
Laurie Roberts |
Correspondent |
Sunrise Medical (US) LLC |
2842 Business Park Ave. |
Fresno,
CA
93727
|
|
Correspondent Contact |
Laurie Roberts |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 09/02/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|