Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K012643 |
Device Name |
APEX MEDICAL LCD TENS-VII |
Applicant |
APEX MEDICAL CORP. |
10TH FLOOR, NO.31, LANE 169 |
KANG NING STREET |
HSI-CHIH CITY, TAIPEI HSIEN,
TW
|
|
Applicant Contact |
ALAN CHANG |
Correspondent |
APEX MEDICAL CORP. |
10TH FLOOR, NO.31, LANE 169 |
KANG NING STREET |
HSI-CHIH CITY, TAIPEI HSIEN,
TW
|
|
Correspondent Contact |
ALAN CHANG |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 10/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|