DSJ MASSAGER


Device Classification Name

massager, powered inflatable tube

510(k) Number K112479
Device Name DSJ MASSAGER
Applicant
MEGO AFEK AC LTD
1050 connecticut avenue, nw.
washington, 
DC 
20036

Applicant Contact james r ravitz, esq.
Correspondent
MEGO AFEK AC LTD
1050 connecticut avenue, nw.
washington, 
DC 
20036

Correspodent Contact james r ravitz, esq.
Regulation Number 890.5650
Classification Product Code
IRP  
Date Received 08/29/2011
Decision Date 12/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No