Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K102051 |
Device Name |
PAIN BUDDY |
Applicant |
BIOMEDICAL LIFE SYSTEMS, INC. |
P.O. BOX 1360 |
VISTA,
CA
92085 -1360
|
|
Applicant Contact |
GARY BUSSETT |
Correspondent |
BIOMEDICAL LIFE SYSTEMS, INC. |
P.O. BOX 1360 |
VISTA,
CA
92085 -1360
|
|
Correspondent Contact |
GARY BUSSETT |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/21/2010 |
Decision Date | 07/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|