Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K123075 |
Device Name |
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E |
Applicant |
WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 |
JUNGJENG RD. |
YUNGHE CITY, TAIPEI COUNTY,
TW
CH
|
|
Applicant Contact |
CHIN-CHIH HSIEH |
Correspondent |
WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 |
JUNGJENG RD. |
YUNGHE CITY, TAIPEI COUNTY,
TW
CH
|
|
Correspondent Contact |
CHIN-CHIH HSIEH |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 10/01/2012 |
Decision Date | 07/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|