2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM

Massager, Powered Inflatable Tube

BIO COMPRESSION SYSTEMS, INC.

The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for 2004-oc Massage System, 2008-oc Massage System.

Pre-market Notification Details

Device IDK122112
510k NumberK122112
Device Name:2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
ClassificationMassager, Powered Inflatable Tube
Applicant BIO COMPRESSION SYSTEMS, INC. 1983 Hazelwood Road Toms River,  NJ  08754
ContactMaureen Garner
CorrespondentMaureen Garner
BIO COMPRESSION SYSTEMS, INC. 1983 Hazelwood Road Toms River,  NJ  08754
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-17
Decision Date2013-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812311021236 K122112 000

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