2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM


Device Classification Name

massager, powered inflatable tube

510(k) Number K122112
Device Name 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
Applicant
BIO COMPRESSION SYSTEMS, INC.
1983 hazelwood road
toms river, 
NJ 
08754

Applicant Contact maureen garner
Correspondent
BIO COMPRESSION SYSTEMS, INC.
1983 hazelwood road
toms river, 
NJ 
08754

Correspodent Contact maureen garner
Regulation Number 890.5650
Classification Product Code
IRP  
Date Received 07/17/2012
Decision Date 04/09/2013
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