Device Classification Name |
Transport, Patient, Powered
|
510(k) Number |
K111858 |
Device Name |
LIFTKAR PT |
Applicant |
SANO TRANSPORTGERAETE GMBH |
428 BELLEAIRE LANE |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
JEANINE A CARROCCIO |
Correspondent |
SANO TRANSPORTGERAETE GMBH |
428 BELLEAIRE LANE |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
JEANINE A CARROCCIO |
Regulation Number | 890.5150 |
Classification Product Code |
|
Date Received | 06/30/2011 |
Decision Date | 11/04/2011 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|