Device Classification Name |
Transport, Patient, Powered
|
510(k) Number |
K121560 |
Device Name |
LEVANT, HOMEGLIDE |
Applicant |
THYSSENKRUPP ACCESSIBILITY B.V. |
VAN UTRECHTWEG 99 |
KRIMPEN AAN DEN IJSSEL |
ZUID-HOLLAND,
NL
2921 LN
|
|
Applicant Contact |
ARNOLD HEIDEN |
Correspondent |
THYSSENKRUPP ACCESSIBILITY B.V. |
VAN UTRECHTWEG 99 |
KRIMPEN AAN DEN IJSSEL |
ZUID-HOLLAND,
NL
2921 LN
|
|
Correspondent Contact |
ARNOLD HEIDEN |
Regulation Number | 890.5150
|
Classification Product Code |
|
Date Received | 05/29/2012 |
Decision Date | 11/01/2012 |
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
|
|
|