Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K162630 |
Device Name |
CP Relief Wand-OTC |
Applicant |
Mid-America Medical Innovations LLC |
2704 Industrial Drive |
Jefferson City,
MO
65109
|
|
Applicant Contact |
Norm Schroeder |
Correspondent |
Mid-America Medical Innovations LLC |
2704 Industrial Drive |
Jefferson City,
MO
65109
|
|
Correspondent Contact |
Norm Schroeder |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/21/2016 |
Decision Date | 12/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|