Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K181955 |
Device Name |
WiEMSpro |
Applicant |
Medical Cables, S.L. |
Duque de la Victoria 6, 1 |
Malaga,
ES
29015
|
|
Applicant Contact |
Jose Fuertes Pena |
Correspondent |
Medical Cables, S.L. |
Duque de la Victoria 6, 1 |
Malaga,
ES
29015
|
|
Correspondent Contact |
Jose Fuertes Pena |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/23/2018 |
Decision Date | 02/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|