Device Classification Name |
Interferential Current Therapy
|
510(k) Number |
K992652 |
Device Name |
SD-730 IF-SDS, PERFECT PULSE IF-SDS |
Applicant |
SKYLARK DEVICE & SYSTEMS CO., LTD |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Applicant Contact |
GEORGE K.C. CHEN |
Correspondent |
SKYLARK DEVICE & SYSTEMS CO., LTD |
34 CHUNG SHAN NORTH RD., |
12TH FL., SEC. 3 |
TAIPEI,
TW
|
|
Correspondent Contact |
GEORGE K.C. CHEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/06/1999 |
Decision Date | 02/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|