Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K032720 |
Device Name |
GEM-STIM TENS, MODELS GM3XY AND GM3AXY |
Applicant |
GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 |
CHUNG CHENG E. RD. |
TAN SHUI, TAIPEI HSIEN,
TW
|
|
Applicant Contact |
BODEN S.P. LAI |
Correspondent |
GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 |
CHUNG CHENG E. RD. |
TAN SHUI, TAIPEI HSIEN,
TW
|
|
Correspondent Contact |
BODEN S.P. LAI |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/02/2003 |
Decision Date | 12/10/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|