Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K152676 |
Device Name |
FD TENS 2090, FD TENS 2095 |
Applicant |
FUJI DYNAMICS LTD |
1-3, 23/F., LAWS COMMERICAL |
PLAZA ,788 CHEUNG SHA WAN RD |
HONG KONG,
CN
|
|
Applicant Contact |
MAN CHUNG MAN |
Correspondent |
FUJI DYNAMICS LTD |
1-3, 23/F., LAWS COMMERICAL |
PLAZA ,788 CHEUNG SHA WAN RD |
HONG KONG,
CN
|
|
Correspondent Contact |
MAN CHUNG MAN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2015 |
Decision Date | 01/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|