Medical Device Manufacturer · US , Moonachie , NJ

Bio Compression Systems, Inc.

15 submissions · 15 cleared · Since 1996
15
Total
15
Cleared
0
Denied

Bio Compression Systems, Inc. — FDA 510(k) Submissions

Bio Compression Systems, Inc. has submitted 15 FDA 510(k) premarket notifications since 1996, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sleeve, Limb, Compressible, Massager, Powered Inflatable Tube, Pack, Hot Or Cold, Water Circulating . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW Sleeve, Limb, Compressible · Cardiovascular
Dec 2025 256d
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K213533 · IRP Massager, Powered... · Physical Medicine
Feb 2022 103d
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K210417 · JOW Sleeve, Limb, Compressible · Cardiovascular
May 2021 92d
VascuEase IC-1200-WH
K180248 · JOW Sleeve, Limb, Compressible · Cardiovascular
Aug 2018 190d
Sequential Circulator SC-2004FC-OC
K171793 · JOW Sleeve, Limb, Compressible · Cardiovascular
Aug 2017 62d
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · JOW Sleeve, Limb, Compressible · Cardiovascular
Jul 2015 98d
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
K142640 · JOW Sleeve, Limb, Compressible · Cardiovascular
Nov 2014 50d
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · JOW Sleeve, Limb, Compressible · Cardiovascular
Jul 2013 76d
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K131327 · JOW Sleeve, Limb, Compressible · Cardiovascular
Jul 2013 71d
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
K122112 · IRP Massager, Powered... · Physical Medicine
Apr 2013 266d
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K072666 · JOW Sleeve, Limb, Compressible · Cardiovascular
Nov 2007 45d
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
K061857 · JOW Sleeve, Limb, Compressible · Cardiovascular
Aug 2006 32d
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · JOW Sleeve, Limb, Compressible · Cardiovascular
Feb 2005 50d
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
K961425 · ILO Pack, Hot Or Cold, Water... · Physical Medicine
Oct 1996 199d
BIO BOOST
K961426 · IRP Massager, Powered... · Physical Medicine
Oct 1996 199d
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