Device Classification Name |
Stimulator, Neuromuscular, External Functional
|
510(k) Number |
K213925 |
Device Name |
MyoCycle MC-2 (Home / Home + / Pro / Pro +) |
Applicant |
Myolyn, LLC |
6931 NW 22nd Street, Suite A |
Gainesville,
FL
32653 -1231
|
|
Applicant Contact |
Matthew Bellman |
Correspondent |
Myolyn, LLC |
6931 NW 22nd Street, Suite A |
Gainesville,
FL
32653 -1231
|
|
Correspondent Contact |
Matthew Bellman |
Regulation Number | 882.5810
|
Classification Product Code |
|
Date Received | 12/16/2021 |
Decision Date | 04/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|