FDA Product Code
FDA Product Code IRP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5650
510(k) Clearances — 156 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017-09-29 | Traditional | PDF ↗ |
| K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd. | 2017-02-23 | Traditional | PDF ↗ |
| K163280 | RP Lite 760R | Mego Afek AC , Ltd. | 2017-01-27 | Special | PDF ↗ |
| K160178 | Lympha-Flow(LF1200) | Daesung Maref Co., Ltd. | 2017-01-11 | Special | PDF ↗ |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016-04-13 | Traditional | PDF ↗ |
| K150269 | Ballancer 505 System, Model 1201-AC | Mego Afek AC , Ltd. | 2015-05-26 | Traditional | PDF ↗ |
| K150033 | Air Compressible Limb Therapy System | Daesung Maref Co., Ltd. | 2015-04-20 | Special | PDF ↗ |
| K143197 | Nice1 | Nice Recovery Systems, LLC | 2014-12-23 | Traditional | PDF ↗ |
| K140519 | RECOVERY PUMP 737R | Mego Afek AC , Ltd. | 2014-06-16 | Traditional | PDF ↗ |
| K133483 | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE | Portable Therapeutix | 2014-03-11 | Traditional | PDF ↗ |
| K130385 | COMPRESSIBLE LIMB SLEEVE SYSTEM | Maxstar Industrial Co., Ltd. | 2014-02-18 | Traditional | PDF ↗ |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | Bio Compression Systems, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K123829 | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK | Portable Therapeutix, LLC | 2013-04-03 | Traditional | PDF ↗ |
| K122154 | POWERPLAY MUSCLE MASSAGER | Fig, LLC | 2012-11-21 | Traditional | PDF ↗ |
| K120166 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM | Won Industrial Co. | 2012-05-14 | Traditional | PDF ↗ |
| K113275 | COMPRESSIBLE LIMB THERAPY SYSTEM | Wonjin Mulsan Co., Ltd. | 2012-02-27 | Traditional | PDF ↗ |
| K112441 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM | Daesung Maref Co., Ltd. | 2012-01-17 | Traditional | PDF ↗ |
| K112890 | NORMATEC MVP | NormaTec Industries, LP | 2012-01-04 | Traditional | PDF ↗ |
| K112479 | DSJ MASSAGER | Mego Afek AC , Ltd. | 2011-12-07 | Traditional | PDF ↗ |
| K102320 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7) | Daesung Maref Co., Ltd. | 2011-03-04 | Traditional | PDF ↗ |
| K102319 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 | Won Industrial Co. | 2011-01-28 | Traditional | PDF ↗ |
| K100656 | COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) | Wonjin Mulsan Co., Ltd. | 2010-05-26 | Special | PDF ↗ |
| K092435 | VERSEO AIR PRESSURE MASSAGER | The American Export Group & International Services | 2010-03-09 | Traditional | PDF ↗ |
| K080134 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) | Wonjin Mulsan Co., Ltd. | 2009-01-23 | Traditional | PDF ↗ |
| K071596 | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008-02-15 | Traditional | PDF ↗ |
| K072620 | GAME READY CLASSIC SYSTEM, MODEL 550550 | Coolsystems, Inc. | 2007-10-31 | Traditional | PDF ↗ |
| K071050 | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM | Coolsystems, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K040905 | WELLNESS/JOLIVETE | Tohkai Precision Ind. , Ltd. | 2005-02-23 | Traditional | PDF ↗ |
| K032505 | AIR PRESS MASSAGER | Telebrands Corp | 2003-09-24 | Traditional | PDF ↗ |
| K030437 | RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM | Salton, Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K013061 | BIOTOUCH MASSAGE THERAPY SYSTEM | Tactile Systems Technology, Inc. | 2002-07-01 | Traditional | PDF ↗ |
| K003909 | PROACT 1 | Proact Co. | 2001-06-13 | Traditional | PDF ↗ |
| K000655 | PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE | Ahava Stein | 2001-03-26 | Traditional | PDF ↗ |
| K994057 | SLENDAIR 4000 COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-03-03 | Traditional | PDF ↗ |
| K991921 | INTERMITTENT COMPRESSION BOOT FOR OTC | Eischoco, Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K974395 | ATLANT'S | Grad-Line Corp. | 1998-10-22 | Traditional | PDF ↗ |
| K964957 | INTERMITTENT COMPRESSOR SYSTEM | Eischoco, Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K961426 | BIO BOOST | Bio Compression Systems, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K953516 | MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP | Yoav Gershoni | 1995-12-08 | Traditional | PDF ↗ |
| K951769 | CRYOPRESS | Grimm Scientific Industries, Inc. | 1995-10-16 | Traditional | PDF ↗ |
| K915092 | TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST | Progressive Medical Technology, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K915638 | TALLEY TM200 INTERMTTENT COMPRESSION UNIT | Progressive Medical Technology, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K915637 | TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. | Progressive Medical Technology, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K914774 | MULTIPULSE SEQUENTIAL COMPRESSION UNIT | Talley Group, Ltd. | 1992-02-11 | Traditional | PDF ↗ |
| K914142 | HEMO-PULSE 2000 | Chrono Dynamics, Ltd. | 1992-01-03 | Traditional | PDF ↗ |
| K912004 | SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS | Shepherd Medical Products, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K901022 | POWERED INFLATABLE TUBE MASSAGER, SPORT-MED | Damor America, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K893950 | VENTIPRESS 24 AND 14 PRESSURE VENTILATOR | Ventipress OY | 1989-08-03 | Traditional | PDF ↗ |
| K874688 | FLOWTRON AC200/2 | Huntleigh Technology, Inc. | 1988-09-23 | Traditional | PDF ↗ |
| K860632 | EBI HAND MASSAGING PUMP (HMP) | Electro-Biology, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K852264 | EBI FOOT MASSAGING PUMP | Electro-Biology, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K834507 | HYDROPULSE(GROSSAN);INFLAT TUBE MASS | Amrex-Zetron, Inc. | 1984-01-17 | Traditional | PDF ↗ |
| K832920 | INTERMITTENT COMPRESSION PUMPS | Chattanooga Group, Inc. | 1983-11-07 | Traditional | PDF ↗ |
| K821920 | I.C.E. BOX | Lhs Industries | 1982-08-31 | Traditional | PDF ↗ |
| K781964 | COMPRESSION DEVICES, LIMB | Alba-Waldensian, Inc. | 1978-12-12 | Traditional | PDF ↗ |
| K780710 | AIR MASSAGE SYSTEM | Theracom C/O Arent, Fox, Kintner, Plotki | 1978-05-09 | Traditional | PDF ↗ |
Product code IRP · Class II · Physical Medicine. Data: openFDA.