PAINSHIELD MD


Device Classification Name

stationary ultrasonic diathermy device for use in applying therapeutic deep heat

510(k) Number K081075
Device Name PAINSHIELD MD
Applicant
NANO VIBRONIX LTD.
pob 6718
efrat, 

IL

90435

Applicant Contact eli orbach
Correspondent
NANO VIBRONIX LTD.
pob 6718
efrat, 

IL

90435

Correspodent Contact eli orbach
Regulation Number 890.5300
Classification Product Code
PFW  
Date Received 04/16/2008
Decision Date 08/22/2008
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