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 |
| K223164 | Aquilo SPorts LLC | Aquilo Sports CCT1500 System | 11/04/2022 |
| K243572 | Avanos Medical, Inc. | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game R | 01/31/2025 |
| 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 |
| K213533 | Bio Compression Systems, Inc. | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | 02/16/2022 |
| K183702 | Breg Inc. | Polar Care Wave | 03/01/2019 |
| K222669 | Chengdu Cryo-Push Medical Technology Co., Ltd | Cryopush Cold Compression Device | 12/05/2022 |
| K230524 | Chengdu Cryo-Push Medical Technology Co.,Ltd | Cold Compression Wrap Pro | 01/19/2024 |
| K192114 | Cool Systems, Inc. (dba Game Ready) | Game Ready GRPro 2.1 System | 10/29/2019 |
| 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 |
| K203019 | DaeSung Maref Co., Ltd | LF900 | 06/22/2021 |
| K231437 | Daesung Maref Co., Ltd | LF900 | 07/19/2023 |
| K160178 | DaeSung Maref Co., Ltd | Lympha-Flow(LF1200) | 01/11/2017 |
| K202395 | DaeSung Maref Co., Ltd | SP-1000, SP-2000 | 09/01/2021 |
| 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 |
| K203498 | Daesung Maref CO., LTD. | LX9max | 07/02/2021 |
| K211460 | Diode Art Engineering doing business as Air Relax | Air Relax Plus Model AR-3.0 | 05/25/2021 |
| K212491 | Diode Art Engineering doing business as Air Relax | Air Relax Pro Model AR-4.0 | 09/02/2021 |
| K991921 | EISCHOCO, INC. | INTERMITTENT COMPRESSION BOOT FOR OTC | 08/13/1999 |
| K964957 | EISCHOCO, INC. | INTERMITTENT COMPRESSOR SYSTEM | 02/24/1997 |
| K243177 | ElastiMed Ltd. | SACS PRO | 12/23/2024 |
| K202693 | Eva Medtec, Inc | NeoWave Pain Relief and Recovery System, Model# T16-2020 | 03/05/2021 |
| K122154 | FIG, LLC | POWERPLAY MUSCLE MASSAGER | 11/21/2012 |
| K210281 | Fist Assist Devices, LLC | Fist Assist Devices Model FA-1 | 06/17/2021 |
| K201730 | Foggiare Technologies LLC | Powered Inflatable Tube Massager - SLIM UP DRAIN | 08/22/2022 |
| K201982 | Foshan Hongfeng Co., Ltd | Air compression therapy system FO-3001; Air compression therapy system FO-3008 | 03/25/2021 |
| K212169 | Foshan Hongfeng Co., Ltd. | Air compression therapy system FO3002 | 11/23/2021 |
| K974395 | GRAD-LINE CORP. | ATLANT'S | 10/22/1998 |
| K250244 | Guangzhou Longest Medical Technology Co., Ltd. | Compression Therapy Device (LGT-2210DS) | 07/25/2025 |
| K191862 | Guangzhou Longest Science & Technology Co., Ltd. | Compression Therapy Device Model LGT-2200SP | 10/29/2019 |
| K202044 | Hanuri Distribution, Inc | Powerpress Recovery Unit | 10/21/2020 |
| K240981 | Huizhou XINYI Technology Co., Ltd. | Air compression leg massager | 08/02/2024 |
| K221862 | Huizhou XINYI Technology Co., LTD. | YY-A02-B Overlapped Compression Therapy | 12/08/2022 |
| K242140 | Jiale Health Technology Shenzhen Co., Ltd. | Air Compression Leg Massager (K-705) | 03/17/2025 |
| K230500 | Jiangsu MaxF Electric Appliance Co., Ltd | Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | 10/26/2023 |
| K240986 | JKH Health Co., Ltd. | Cold Compression | 05/01/2024 |
| K223541 | JKH Health Co., Ltd. | Cold/Hot Compression | 10/27/2023 |
| K201645 | JKH USA, LLC | Massage Compression Boots | 09/15/2020 |
| K210240 | Konliking Tech & Dev. Limited | Air Compression Therapy Device, model HW6007 | 02/22/2021 |
| K200351 | ManaMed, Inc. | PlasmaFlight | 08/05/2020 |
| K130385 | MAXSTAR INDUSTRIAL CO. LTD. | COMPRESSIBLE LIMB SLEEVE SYSTEM | 02/18/2014 |
| K173158 | Maxstar Industrial Co., Ltd | Air Relax | 05/30/2019 |
| K191441 | Maxstar Industrial Co., Ltd. | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | 03/05/2021 |
| K223729 | Medella Health Limited | FLOWpresso | 12/21/2023 |
| K994057 | MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. | SLENDAIR 4000 COMPRESSION SYSTEM | 03/03/2000 |
| K230385 | Mego Afek | Ballancer Platinum (1222) | 04/04/2023 |
| 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 |
| K193079 | mks paris | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | 01/11/2021 |
| 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 |
| K220217 | NormaTec Industries, LP | Normatec 3 | 02/25/2022 |
| K240122 | NormaTec Industries, LP | Normatec Elite | 03/21/2024 |
| K221666 | NormaTec Industries, LP | Normatec Go | 07/14/2022 |
| 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 |
| K203552 | Rapid Reboot Recovery Products, LLC | Rapid Reboot | 12/22/2020 |
| 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 |
| K193354 | Shenzhen Dongjilian Electronics Co.,Ltd. | Air Compression Therapy Device | 06/08/2020 |
| K201694 | Shenzhen Dongjilian Electronics Co.,Ltd. | Air Compression Therapy Device | 11/19/2020 |
| K222206 | Shenzhen Dongjilian Medical Tech Co., Ltd. | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) | 09/30/2022 |
| K233536 | Shenzhen Dongjilian Medical Tech Co., Ltd. | Air Compression Recovery System | 12/16/2023 |
| K213745 | Shenzhen Future Electronic Co., Ltd | Air Compression Therapy Device, model: ST-502 | 03/31/2022 |
| K192466 | Shenzhen Lifotronic Technology Co., Ltd. | Air Compression Therapy System | 06/22/2020 |
| K232965 | Shenzhen Ruiyi Business Technology Co., Ltd. | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | 11/20/2024 |
| K222924 | Shenzhen Ruiyi Business Technology Co., Ltd. | Leg Massager RF-ALM070 | 12/23/2022 |
| K250046 | Shenzhen Urion Technology Co., Ltd. | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | 04/25/2025 |
| K242940 | SHENZHEN XINRUN ELECTRIC APPLIANCES CO LTD | Xrecovery (XR-001) | 11/14/2024 |
| K241446 | Sichuan QianIi-beoka Medical TechnoIogy lnc. | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | 10/08/2024 |
| K243206 | Sichuan Qianli-beoka Medical Technology Inc. | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) | 02/19/2025 |
| K210913 | SLK Medical GmbH | V12 PRO | 08/04/2021 |
| K222136 | Suzhou MicroPort RehabTech (Group) Co., Ltd. | Cryo-Thermo Compression Device (FGK002) | 03/08/2023 |
| K013061 | TACTILE SYSTEMS TECHNOLOGY INC | BIOTOUCH MASSAGE THERAPY SYSTEM | 07/01/2002 |
| K032505 | TELEBRANDS CORP | AIR PRESS MASSAGER | 09/24/2003 |
| K092435 | THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES | VERSEO AIR PRESSURE MASSAGER | 03/09/2010 |
| K241256 | Therabody, Inc. | JetBoots PRO Plus | 08/30/2024 |
| K211745 | Theragun, Inc. | RecoveryAir PRO | 10/04/2021 |
| K040905 | TOHKAI PRECISION IND. LTD. | WELLNESS/JOLIVETE | 02/23/2005 |
| K192607 | Viasonix Ltd. | LiteWalk | 12/19/2019 |
| K213000 | Wenzhou Lingfeng Electronic Technology Co., Ltd | Air Compression Massager (Model LF-FT003) | 11/15/2021 |
| 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 |
| K200660 | Wonjin Mulsan Co., Ltd | Compressible Limb and Circulation Therapy System | 03/08/2021 |
| K211283 | Wonjin Mulsan Co., Ltd. | Compressible Limb and Circulation Therapy System, Model POWER-Q2300 | 09/14/2021 |
| 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 |
| K222991 | Xiamen Emoka Health Science & Technology Co., Ltd. | Air Compression Leg Massager (model: EMK-701) | 03/15/2023 |
| K211850 | Xiamen Healthpal Electronic Co.,Ltd | Air Compression Leg Massager (model: FE-7204B) | 03/03/2022 |
| K212713 | Xiamen High Top Electronic Technology Co., Ltd. | Air compression leg massager HY-1117A | 01/18/2022 |
| K161907 | XIAMEN SENYANG CO., LTD. | Pressure Therapy System | 02/23/2017 |
| K181409 | Xiamen Senyang Co., Ltd. | Pressure Therapy System PT1003 | 02/19/2019 |
| K192358 | Xiamen Senyang Co., Ltd. | Pressure Therapy System PT1003 | 04/23/2020 |
| K212935 | Xiamen Simo Electronic Co., Ltd | Air Pressure Foot Massager | 02/19/2022 |
| K242615 | Xiamen Taotao Technology Co.,Ltd. | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | 07/23/2025 |
| K233238 | Xiamen Weiyou Intelligent Technology Co., Ltd. | Air Pressure Therapy System (Model:VU-IPC4M) | 06/14/2024 |
| K210967 | Xiamen Weiyou Intelligent Technology Co., Ltd. | Air Pressure Therapy System: VU-IPC06 | 05/11/2021 |
| K201935 | Xiamen Weiyou Intelligent Technology Co.,Ltd | Air Pressure Therapy System | 06/22/2021 |
| K243791 | Xiamen WeiYou Intelligent Technology Co.,Ltd. | Air Pressure Therapy System | 01/13/2025 |
| K243320 | Xiamen WeiYou Intelligent Technology Co.,Ltd. | Air Pressure Therapy System (VU-IPC04B) | 11/18/2024 |
| K242754 | ZAMAR Medical d.o.o. | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | 05/05/2025 |
| K190854 | Zenith Technical Innovations | Therm-X | 05/10/2019 |
| K193550 | Zenith Technical Innovations | Therm-X | 02/28/2020 |
| K231912 | Zenith Technical Innovations | Therm-X | 07/27/2023 |
| K181149 | Zenith Technical Innovations | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | 08/03/2018 |
| K223464 | Zhangzhou Easepal Innovation Co Ltd. | Leg and Foot Air Wave Pressure Therapy Device | 03/14/2023 |
| K240373 | Zhangzhou Easepal Medical Science And Technology Co., Ltd. | Air compression Leg Massager (MM0520, MM0521, MM0522) | 09/17/2024 |
| K222949 | Zhejiang Luyao Electronics Technology Co., Ltd | Air Compression Leg Massager (Model: LY-670D) | 12/22/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
