Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K945676 |
Device Name |
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES |
Applicant |
SELECTIVE MED COMPONENTS, INC. |
208 W. HIGH ST. |
MT. VERNON,
OH
43050
|
|
Applicant Contact |
RICHARD J FISHER, JR |
Correspondent |
SELECTIVE MED COMPONENTS, INC. |
208 W. HIGH ST. |
MT. VERNON,
OH
43050
|
|
Correspondent Contact |
RICHARD J FISHER, JR |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/18/1994 |
Decision Date | 01/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|