Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K102786 |
Device Name |
WELL-LIFE OTC EMS SYSTEM |
Applicant |
WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 |
JUNGJENG RD. |
YUNGHE CITY, TAIPEI COUNTY,
TW
234
|
|
Applicant Contact |
JENNY HSIEH |
Correspondent |
WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 |
JUNGJENG RD. |
YUNGHE CITY, TAIPEI COUNTY,
TW
234
|
|
Correspondent Contact |
JENNY HSIEH |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 09/27/2010 |
Decision Date | 07/01/2011 |
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
|
|
|