Device Classification Name |
Interactive Rehabilitation Exercise Devices
|
510(k) Number |
K173931 |
Device Name |
MindMotion(TM) GO |
Applicant |
MindMaze SA |
Chemin de Roseneck 5 |
Lausanne,
CH
CH-1006
|
|
Applicant Contact |
Sylvian Bourriquet |
Correspondent |
MindMaze SA |
Chemin de Roseneck 5 |
Lausanne,
CH
CH-1006
|
|
Correspondent Contact |
Sylvian Bourriquet |
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 12/26/2017 |
Decision Date | 05/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|