Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K081255 |
Device Name |
SCRAMBLER ST 5 TENS DEVICE |
Applicant |
COMPETITIVE TECHNOLOGIES,INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -2
|
|
Applicant Contact |
MARY MCNAMARA |
Correspondent |
COMPETITIVE TECHNOLOGIES,INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -2
|
|
Correspondent Contact |
MARY MCNAMARA |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 05/02/2008 |
Decision Date | 02/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|