Device Classification Name |
powered exoskeleton
|
510(k) Number |
K200032 |
Device Name |
ReWalk P6.0 |
Applicant |
ReWalk Robotics Ltd. |
3 Hetnufa st., POB Box- 161 |
Yokneam,
IL
2069203
|
|
Applicant Contact |
Ofir Koren |
Correspondent |
ReWalk Robotics Ltd. |
3 Hetnufa st., POB Box- 161 |
Yokneam,
IL
2069203
|
|
Correspondent Contact |
Ofir Koren |
Regulation Number | 890.3480
|
Classification Product Code |
|
Date Received | 01/07/2020 |
Decision Date | 05/26/2020 |
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
|
Recalls |
CDRH Recalls
|
|
|