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 |
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 |
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 |
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 |
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 |
K221862 |
Huizhou XINYI Technology Co., LTD. |
YY-A02-B Overlapped Compression Therapy |
12/08/2022 |
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 |
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 |
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 |
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 |
K222924 |
Shenzhen Ruiyi Business Technology Co., Ltd. |
Leg Massager RF-ALM070 |
12/23/2022 |
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 |
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 |
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 |
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 |
K222949 |
Zhejiang Luyao Electronics Technology Co., Ltd |
Air Compression Leg Massager (Model: LY-670D) |
12/22/2022 |