Panels › Physical Medicine › Product code IRP · Class 2
Massager, Powered Inflatable Tube
Regulation 890.5650
13510(k)s in 12 months (158 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in IRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Daesung Maref Co., Ltd. | 8 | 0 |
| NormaTec Industries, LP | 8 | 0 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | 7 | 0 |
| Mego Afek AC , Ltd. | 6 | 0 |
| Wonjin Mulsan Co., Ltd. | 5 | 0 |
| Chengdu Cryo-Push Medical Technology Co.,Ltd | 4 | 0 |
| Zenith Technical Innovations | 4 | 0 |
| Bio Compression Systems, Inc. | 3 | 0 |
| Coolsystems, Inc. | 2 | 1 |
| Jkh Health Co., Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2018 | K182668 | Rapid Reboot Compression Therapy System Rapid Reboot Recovery Products, LLC | IRP |
| Aug 3, 2018 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations | IRP |
| Sep 29, 2017 | K171685 | Med4 Elite Cool Systems, Inc. (Dba Game Ready) | IRP |
| Feb 23, 2017 | K161907 | Pressure Therapy System Xiamen Senyang Co., Ltd., CN | IRP |
| Jan 27, 2017 | K163280 | RP Lite 760R Mego Afek AC , Ltd., IL | IRP |
| Jan 11, 2017 | K160178 | Lympha-Flow(LF1200) Daesung Maref Co., Ltd., KR | IRP |
| Apr 13, 2016 | K160608 | NormaTec Pulse and NormaTec Pulse Pro NormaTec Industries, LP | IRP |
| May 26, 2015 | K150269 | Ballancer 505 System, Model 1201-AC Mego Afek AC , Ltd., IL | IRP |
| Apr 20, 2015 | K150033 | Air Compressible Limb Therapy System Daesung Maref Co., Ltd., KR | IRP |
| Dec 23, 2014 | K143197 | Nice1 Nice Recovery Systems, LLC | IRP |
| Jun 16, 2014 | K140519 | RECOVERY PUMP 737R Mego Afek AC , Ltd., IL | IRP |
| Mar 11, 2014 | K133483 | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE Portable Therapeutix | IRP |
| Feb 18, 2014 | K130385 | COMPRESSIBLE LIMB SLEEVE SYSTEM Maxstar Industrial Co., Ltd. | IRP |
| Apr 9, 2013 | K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM Bio Compression Systems, Inc. | IRP |
| Apr 3, 2013 | K123829 | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK Portable Therapeutix, LLC | IRP |
| Nov 21, 2012 | K122154 | POWERPLAY MUSCLE MASSAGER Fig, LLC | IRP |
| May 14, 2012 | K120166 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM Won Industrial Co. | IRP |
| Feb 27, 2012 | K113275 | COMPRESSIBLE LIMB THERAPY SYSTEM Wonjin Mulsan Co., Ltd., KR | IRP |
| Jan 17, 2012 | K112441 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM Daesung Maref Co., Ltd. | IRP |
| Jan 4, 2012 | K112890 | NORMATEC MVP NormaTec Industries, LP | IRP |
| Dec 7, 2011 | K112479 | DSJ MASSAGER Mego Afek AC , Ltd. | IRP |
| Mar 4, 2011 | K102320 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) Daesung Maref Co., Ltd. | IRP |
| Jan 28, 2011 | K102319 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 Won Industrial Co. | IRP |
| May 26, 2010 | K100656 | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) Wonjin Mulsan Co., Ltd. | IRP |
| Mar 9, 2010 | K092435 | VERSEO AIR PRESSURE MASSAGER The American Export Group & International Services | IRP |
| Jan 23, 2009 | K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) Wonjin Mulsan Co., Ltd. | IRP |
| Feb 15, 2008 | K071596 | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 Nihon Seimitsu Sokki Co., Ltd., JP | IRP |
| Oct 31, 2007 | K072620 | GAME READY CLASSIC SYSTEM, MODEL 550550 Coolsystems, Inc. | IRP |
| Jun 29, 2007 | K071050 | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM Coolsystems, Inc. | IRP |
| Feb 23, 2005 | K040905 | WELLNESS/JOLIVETE Tohkai Precision Ind. , Ltd. | IRP |
| Sep 24, 2003 | K032505 | AIR PRESS MASSAGER Telebrands Corp | IRP |
| Apr 10, 2003 | K030437 | RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM Salton, Inc. | IRP |
| Jul 1, 2002 | K013061 | BIOTOUCH MASSAGE THERAPY SYSTEM Tactile Systems Technology, Inc. | IRP |
| Jun 13, 2001 | K003909 | PROACT 1 Proact Co. | IRP |
| Mar 26, 2001 | K000655 | PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE Ahava Stein, IL | IRP |
| Mar 3, 2000 | K994057 | SLENDAIR 4000 COMPRESSION SYSTEM Medical Compression Systems (Dbn) , Ltd., IL | IRP |
| Aug 13, 1999 | K991921 | INTERMITTENT COMPRESSION BOOT FOR OTC Eischoco, Inc. | IRP |
| Oct 22, 1998 | K974395 | ATLANT'S Grad-Line Corp. | IRP |
| Feb 24, 1997 | K964957 | INTERMITTENT COMPRESSOR SYSTEM Eischoco, Inc. | IRP |
| Oct 28, 1996 | K961426 | BIO BOOST Bio Compression Systems, Inc. | IRP |
| Dec 8, 1995 | K953516 | MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP Yoav Gershoni | IRP |
| Oct 16, 1995 | K951769 | CRYOPRESS Grimm Scientific Industries, Inc. | IRP |
| Feb 11, 1992 | K915638 | TALLEY TM200 INTERMTTENT COMPRESSION UNIT Progressive Medical Technology, Inc. | IRP |
| Feb 11, 1992 | K915637 | TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. Progressive Medical Technology, Inc. | IRP |
| Feb 11, 1992 | K915092 | TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST Progressive Medical Technology, Inc. | IRP |
| Feb 11, 1992 | K914774 | MULTIPULSE SEQUENTIAL COMPRESSION UNIT Talley Group, Ltd. | IRP |
| Jan 3, 1992 | K914142 | HEMO-PULSE 2000 Chrono Dynamics, Ltd. | IRP |
| Jul 25, 1991 | K912004 | SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS Shepherd Medical Products, Inc. | IRP |
| Mar 14, 1990 | K901022 | POWERED INFLATABLE TUBE MASSAGER, SPORT-MED Damor America, Inc. | IRP |
| Aug 3, 1989 | K893950 | VENTIPRESS 24 AND 14 PRESSURE VENTILATOR Ventipress OY, FI | IRP |
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