HEALTHMATEFOREVER


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

Correspodent Contact mei dodson
Regulation Number 882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
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