Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K121757 |
Device Name |
HEALTHMATEFOREVER |
Applicant |
HEALTHMATE INTERNATIONAL, LLC |
709 E. 97TH STREET |
KANSAS CITY,
MO
64131
|
|
Applicant Contact |
MEI DODSON |
Correspondent |
HEALTHMATE INTERNATIONAL, LLC |
709 E. 97TH STREET |
KANSAS CITY,
MO
64131
|
|
Correspondent Contact |
MEI DODSON |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|