Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K111645 |
Device Name |
FD TENS 2050 OR SLIDE TENS MODEL FD2050 |
Applicant |
FUJI DYNAMICS LTD |
UNIT 1-3, 23/F LAWS COMMERICAL |
PLAZA 788 CHEUNG SHA WAN RD |
HONG KONG,
CN
CH
|
|
Applicant Contact |
CHING KONG (FELIX) LEE |
Correspondent |
FUJI DYNAMICS LTD |
UNIT 1-3, 23/F LAWS COMMERICAL |
PLAZA 788 CHEUNG SHA WAN RD |
HONG KONG,
CN
CH
|
|
Correspondent Contact |
CHING KONG (FELIX) LEE |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 06/13/2011 |
Decision Date | 11/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|