ACTITRAINER


Device Classification Name

exerciser, measuring

510(k) Number K080545
Device Name ACTITRAINER
Applicant
ACTIGRAPH, LLC
15 w. main. st
pensacola, 
FL 
32502

Applicant Contact john scheider
Correspondent
ACTIGRAPH, LLC
15 w. main. st
pensacola, 
FL 
32502

Correspodent Contact john scheider
Regulation Number 890.5360
Classification Product Code
ISD  
Date Received 02/27/2008
Decision Date 07/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No