Device Classification Name |
electrode, cutaneous
|
510(k) Number |
K902195 |
Device Name |
TBD TENS REUSABLE ELECTRODE |
Applicant |
EMPI |
1275 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Applicant Contact |
MATTSON, RN |
Correspondent |
EMPI |
1275 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Correspondent Contact |
MATTSON, RN |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 05/16/1990 |
Decision Date | 06/08/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|