Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
510(k) Number |
K233006 |
Device Name |
MyndMove, MyndMove 2.0 |
Applicant |
MyndTec Inc. |
1900 Minnesota Court |
Mississauga,
CA
L5N 3C9
|
|
Applicant Contact |
Yesmil Pena |
Correspondent |
MyndTec Inc. |
1900 Minnesota Court |
Mississauga,
CA
L5N 3C9
|
|
Correspondent Contact |
Yesmil Pena |
Regulation Number | 882.5810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/22/2023 |
Decision Date | 06/25/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|