Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K102278 |
Device Name |
QUADRA BLOC TENS PLUS |
Applicant |
GRADIENT TECHNOLOGIES, LLC |
6070 POPLAR AVENUE |
SIXTH FLOOR |
MEMPHIS,
TN
38119
|
|
Applicant Contact |
JOHN TOWNSEND |
Correspondent |
GRADIENT TECHNOLOGIES, LLC |
6070 POPLAR AVENUE |
SIXTH FLOOR |
MEMPHIS,
TN
38119
|
|
Correspondent Contact |
JOHN TOWNSEND |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/11/2010 |
Decision Date | 10/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|