Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K060846 |
Device Name |
THERAPEUTIC MASSAGE COMPANION |
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 Code |
|
Date Received | 03/28/2006 |
Decision Date | 12/03/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|