ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE


Device Classification Name

diathermy, shortwave, for use other than applying therapeutic deep heat

510(k) Number K121702
Device Name ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
Applicant
ORTHO MEDICAL
200 homer ave.
ashland, 
MA 
01721

Applicant Contact david rothkopf
Correspondent
ORTHO MEDICAL
200 homer ave.
ashland, 
MA 
01721

Correspodent Contact david rothkopf
Regulation Number 890.5290
Classification Product Code
ILX  
Date Received 06/08/2012
Decision Date 05/06/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Physical Medicine

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No