COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)


Device Classification Name

massager, powered inflatable tube

510(k) Number K080134
Device Name COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
Applicant
WONJIN MULSAN CO., LTD.
155 flemington court
la mirada, 
CA 
90638

Applicant Contact brandon choi
Correspondent
WONJIN MULSAN CO., LTD.
155 flemington court
la mirada, 
CA 
90638

Correspodent Contact brandon choi
Regulation Number 890.5650
Classification Product Code
IRP  
Date Received 01/18/2008
Decision Date 01/23/2009
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