Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K905230 |
Device Name |
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A |
Applicant |
BIOMEDICAL LIFE SYSTEMS, INC. |
1285 STONE DR. #103 |
P.O. BOX 128 |
SAN MARCOS,
CA
92069
|
|
Applicant Contact |
RICHARD SAXON |
Correspondent |
BIOMEDICAL LIFE SYSTEMS, INC. |
1285 STONE DR. #103 |
P.O. BOX 128 |
SAN MARCOS,
CA
92069
|
|
Correspondent Contact |
RICHARD SAXON |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 11/20/1990 |
Decision Date | 06/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|