Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K162744 |
Device Name |
Everyway OTC EMS, Model EV-805 |
Applicant |
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
3FL., NO. 5, LANE 155, SECTION 3, |
PEISHEN RD. |
SHENKENG DIST, NEW TAIPEI CITY,
TW
222
|
|
Applicant Contact |
PAUL HUNG |
Correspondent |
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
3FL., NO. 5, LANE 155, SECTION 3, |
PEISHEN RD. |
SHENKENG DIST, NEW TAIPEI CITY,
TW
222
|
|
Correspondent Contact |
PAUL HUNG |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 08/03/2017 |
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
|
|
|