Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K124055 |
Device Name |
T1040 AKA AURAWAVE |
Applicant |
ENDURANCE THERAPEUTICS |
122B - FIRST STREET NE |
DAUPHIN, MANITOBA,
CA
R7N 1B5
|
|
Applicant Contact |
BRAD BREZDEN |
Correspondent |
ENDURANCE THERAPEUTICS |
122B - FIRST STREET NE |
DAUPHIN, MANITOBA,
CA
R7N 1B5
|
|
Correspondent Contact |
BRAD BREZDEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/31/2012 |
Decision Date | 07/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|