Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K091833 |
Device Name |
GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. |
Applicant |
GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 |
CHUNG CHENG E. RD. |
TAN SHUI, TAIPEI HSIEN,
TW
251
|
|
Applicant Contact |
BODEN LAI |
Correspondent |
GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 |
CHUNG CHENG E. RD. |
TAN SHUI, TAIPEI HSIEN,
TW
251
|
|
Correspondent Contact |
BODEN LAI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 06/22/2009 |
Decision Date | 10/16/2009 |
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
|
|
|