Device Classification Name |
Powered Exoskeleton
|
510(k) Number |
K161443 |
Device Name |
Ekso™ (version 1.1) and Ekso GT™ (version 1.2) |
Applicant |
EKSO BIONICS, INC. |
1414 HARBOUR WAY SOUTH, SUITE 1201 |
RICHMOND,
VA
94804
|
|
Applicant Contact |
Thomas Looby |
Correspondent |
HOGAN LOVELLS US LLP |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 890.3480
|
Classification Product Code |
|
Date Received | 05/25/2016 |
Decision Date | 07/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|