FDA 510(k) Applications for Medical Device Product Code "IRP"
(Massager, Powered Inflatable Tube)

FDA 510(k) Number Applicant Device Name Decision Date
K000655 AHAVA STEIN PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE 03/26/2001
K781964 ALBA-WALDENSIAN, INC. COMPRESSION DEVICES, LIMB 12/12/1978
K834507 AMREX-ZETRON, INC. HYDROPULSE(GROSSAN);INFLAT TUBE MASS 01/17/1984
K122112 BIO COMPRESSION SYSTEMS, INC. 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM 04/09/2013
K961426 BIO COMPRESSION SYSTEMS, INC. BIO BOOST 10/28/1996
K183702 Breg Inc. Polar Care Wave 03/01/2019
K832920 CHATTANOOGA GROUP, INC. INTERMITTENT COMPRESSION PUMPS 11/07/1983
K914142 CHRONO DYNAMICS, LTD. HEMO-PULSE 2000 01/03/1992
K171685 Cool Systems, Inc. (dba Game Ready) Med4 Elite 09/29/2017
K072620 COOLSYSTEMS, INC. GAME READY CLASSIC SYSTEM, MODEL 550550 10/31/2007
K071050 COOLSYSTEMS, INC. GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM 06/29/2007
K160178 DaeSung Maref Co., Ltd Lympha-Flow(LF1200) 01/11/2017
K150033 DAESUNG MAREF CO., LTD. Air Compressible Limb Therapy System 04/20/2015
K112441 DAESUNG MAREF CO., LTD. COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM 01/17/2012
K102320 DAESUNG MAREF CO., LTD. COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) 03/04/2011
K901022 DAMOR AMERICA, INC. POWERED INFLATABLE TUBE MASSAGER, SPORT-MED 03/14/1990
K991921 EISCHOCO, INC. INTERMITTENT COMPRESSION BOOT FOR OTC 08/13/1999
K964957 EISCHOCO, INC. INTERMITTENT COMPRESSOR SYSTEM 02/24/1997
K852264 ELECTRO-BIOLOGY, INC. EBI FOOT MASSAGING PUMP 07/19/1985
K860632 ELECTRO-BIOLOGY, INC. EBI HAND MASSAGING PUMP (HMP) 04/18/1986
K122154 FIG, LLC POWERPLAY MUSCLE MASSAGER 11/21/2012
K974395 GRAD-LINE CORP. ATLANT'S 10/22/1998
K951769 GRIMM SCIENTIFIC INDUSTRIES, INC. CRYOPRESS 10/16/1995
K874688 HUNTLEIGH TECHNOLOGY, INC. FLOWTRON AC200/2 09/23/1988
K821920 LHS INDUSTRIES I.C.E. BOX 08/31/1982
K130385 MAXSTAR INDUSTRIAL CO. LTD. COMPRESSIBLE LIMB SLEEVE SYSTEM 02/18/2014
K173158 Maxstar Industrial Co., Ltd Air Relax 05/30/2019
K994057 MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. SLENDAIR 4000 COMPRESSION SYSTEM 03/03/2000
K112479 MEGO AFEK AC LTD DSJ MASSAGER 12/07/2011
K140519 MEGO AFEK AC LTD RECOVERY PUMP 737R 06/16/2014
K150269 Mego Afek AC Ltd. Ballancer 505 System, Model 1201-AC 05/26/2015
K190015 Mego Afek AC Ltd. Ballancer Gold, 1212 03/25/2019
K190493 Mego Afek AC Ltd. Recovery Pump, 737R (RPX) 05/15/2019
K163280 Mego Afek AC Ltd. RP Lite 760R 01/27/2017
K192252 Menlo Brands LLC ProPerformance Recovery System 09/19/2019
K143197 NICE RECOVERY SYSTEMS, LLC Nice1 12/23/2014
K071596 NIHON SEIMITSU SOKKI CO., LTD. POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 02/15/2008
K112890 NORMATEC INDUSTRIES, LP NORMATEC MVP 01/04/2012
K160608 NORMATEC INDUSTRIES, LP NormaTec Pulse and NormaTec Pulse Pro 04/13/2016
K183169 NormaTec Industries, LP Pulse 2.0, Pulse Pro 2.0 12/27/2018
K133483 PORTABLE THERAPEUTIX PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE 03/11/2014
K123829 PORTABLE THERAPEUTIX, LLC PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK 04/03/2013
K003909 PROACT CO. PROACT 1 06/13/2001
K915638 PROGRESSIVE MEDICAL TECHNOLOGY, INC. TALLEY TM200 INTERMTTENT COMPRESSION UNIT 02/11/1992
K915092 PROGRESSIVE MEDICAL TECHNOLOGY, INC. TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST 02/11/1992
K915637 PROGRESSIVE MEDICAL TECHNOLOGY, INC. TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. 02/11/1992
K182668 Rapid Reboot Recovery Products, LLC Rapid Reboot Compression Therapy System 12/14/2018
K030437 SALTON, INC. RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM 04/10/2003
K912004 SHEPHERD MEDICAL PRODUCTS, INC. SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS 07/25/1991
K013061 TACTILE SYSTEMS TECHNOLOGY INC BIOTOUCH MASSAGE THERAPY SYSTEM 07/01/2002
K914774 TALLEY GROUP LTD. MULTIPULSE SEQUENTIAL COMPRESSION UNIT 02/11/1992
K032505 TELEBRANDS CORP AIR PRESS MASSAGER 09/24/2003
K092435 THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES VERSEO AIR PRESSURE MASSAGER 03/09/2010
K780710 THERACOM C/O ARENT, FOX, KINTNER, PLOTKI AIR MASSAGE SYSTEM 05/09/1978
K040905 TOHKAI PRECISION IND. LTD. WELLNESS/JOLIVETE 02/23/2005
K893950 VENTIPRESS OY VENTIPRESS 24 AND 14 PRESSURE VENTILATOR 08/03/1989
K120166 WON INDUSTRIAL CO. COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM 05/14/2012
K102319 WON INDUSTRIAL CO. COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 01/28/2011
K080134 WONJIN MULSAN CO., LTD. COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) 01/23/2009
K100656 WONJIN MULSAN CO., LTD. COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) 05/26/2010
K113275 WONJINMULSAN CO., LTD. COMPRESSIBLE LIMB THERAPY SYSTEM 02/27/2012
K161907 XIAMEN SENYANG CO., LTD. Pressure Therapy System 02/23/2017
K181409 Xiamen Senyang Co., Ltd. Pressure Therapy System PT1003 02/19/2019
K953516 YOAV GERSHONI MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP 12/08/1995
K190854 Zenith Technical Innovations Therm-X 05/10/2019
K181149 Zenith Technical Innovations Therm-X Pro, Therm-X AT, Therm-X Pro Athlete 08/03/2018


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