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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)
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Top companies in IRP

Company510(k)sRecalls
Daesung Maref Co., Ltd.80
NormaTec Industries, LP80
Xiamen Weiyou Intelligent Technology Co., Ltd.70
Mego Afek AC , Ltd.60
Wonjin Mulsan Co., Ltd.50
Chengdu Cryo-Push Medical Technology Co.,Ltd40
Zenith Technical Innovations40
Bio Compression Systems, Inc.30
Coolsystems, Inc.21
Jkh Health Co., Ltd.30
Decided510(k)Device and applicantCode
Oct 6, 2026K261887Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-
NormaTec Industries, LP
IRP
Oct 5, 2026K262812Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-
Sichuan Qianli-Beoka Medical Technology, Inc., CN
IRP
Aug 12, 2026K260944ManaCold Compression System
Manamed, LLC
IRP
Jul 27, 2026K260529Air Compression Massager (HY-1165)
Xiamen High Top Electronic Technology Co., Ltd., CN
IRP
Jul 24, 2026K260948Air Compression Massager (EP30B001 I)
Wavepulse (Xiamen) Healthcare Technology Co., Ltd., CN
IRP
Jun 10, 2026K253919Cryo And Thermo Therapy System
Xiamen Weiyou Intelligent Technology Co., Ltd., CN
IRP
May 29, 2026K252396Cryo Sport 2.0 (AVA 501)
Avanutri Equipamentos DE Saúde, BR
IRP
May 5, 2026K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007,
Wenzhou Lingfeng Electronic Technology Co., Ltd., CN
IRP
Apr 30, 2026K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)
Xiamen Weiyou Intelligent Technology Co., Ltd., CN
IRP
Apr 3, 2026K252386Hot and Cold Compression System (A02-C-032)
Chengdu Cryo-Push Medical Technology Co.,Ltd, CN
IRP
Apr 2, 2026K253076Cryopush Cold Compression Device (A02-P-001)
Chengdu Cryo-Push Medical Technology Co.,Ltd, CN
IRP
Jan 28, 2026K251622Hand Massager (SM004D)
Ningbo Zhenhai Yihao Electronic Technology Co., Ltd., CN
IRP
Nov 13, 2025K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506
Shenzhen Future Electronic Co., Ltd., CN
IRP
Oct 30, 2025K251531AIR COMPRESSION BOOTS 1018195,1018196
Merchsource, LLC
IRP
Oct 24, 2025K253150Cryon-X Cold Compression
Jkh Health Co., Ltd., CN
IRP
Sep 18, 2025K251905Normatec Elite Hip
NormaTec Industries, LP
IRP
Sep 17, 2025K251623Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
Shenzhen Yicai Health Technology Co., Ltd., CN
IRP
Jul 25, 2025K250244Compression Therapy Device (LGT-2210DS)
Guangzhou Longest Medical Technology Co., Ltd., CN
IRP
Jul 23, 2025K242615Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L
Xiamen Taotao Technology Co., Ltd., CN
IRP
May 5, 2025K242754ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
Zamar Medical D.O.O., HR
IRP
Apr 25, 2025K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
Shenzhen Urion Technology Co., Ltd., CN
IRP
Mar 17, 2025K242140Air Compression Leg Massager (K-705)
Jiale Health Technology Shenzhen Co., Ltd., CN
IRP
Feb 19, 2025K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
Sichuan Qianli-Beoka Medical Technology, Inc., CN
IRP
Jan 31, 2025K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04);
Avanos Medical, Inc.
IRP
Jan 13, 2025K243791Air Pressure Therapy System
Xiamen Weiyou Intelligent Technology Co., Ltd., CN
IRP
Dec 23, 2024K243177SACS PRO
Elastimed , Ltd., IL
IRP
Nov 20, 2024K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)
Shenzhen Ruiyi Business Technology Co., Ltd., CN
IRP
Nov 18, 2024K243320Air Pressure Therapy System (VU-IPC04B)
Xiamen Weiyou Intelligent Technology Co., Ltd., CN
IRP
Nov 14, 2024K242940Xrecovery (XR-001)
Shenzhen Xinrun Electric Appliances Co, Ltd., CN
IRP
Oct 8, 2024K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
Sichuan Qianii-Beoka Medical Technoiogy Lnc., CN
IRP
Sep 17, 2024K240373Air compression Leg Massager (MM0520, MM0521, MM0522)
Zhangzhou Easepal Medical Science and Technology Co., Ltd., CN
IRP
Aug 30, 2024K241256JetBoots PRO Plus
Therabody, Inc.
IRP
Aug 2, 2024K240981Air compression leg massager
Huizhou Xinyi Technology Co., Ltd., CN
IRP
Jun 14, 2024K233238Air Pressure Therapy System (Model:VU-IPC4M)
Xiamen Weiyou Intelligent Technology Co., Ltd., CN
IRP
May 1, 2024K240986Cold Compression
Jkh Health Co., Ltd., CN
IRP
Mar 21, 2024K240122Normatec Elite
NormaTec Industries, LP
IRP
Jan 19, 2024K230524Cold Compression Wrap Pro
Chengdu Cryo-Push Medical Technology Co.,Ltd, CN
IRP
Dec 21, 2023K223729FLOWpresso
Medella Health Limited, NZ
IRP
Dec 16, 2023K233536Air Compression Recovery System
Shenzhen Dongjilian Medical Tech Co., Ltd., CN
IRP
Oct 27, 2023K223541Cold/Hot Compression
Jkh Health Co., Ltd., CN
IRP
Oct 26, 2023K230500Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LE
Jiangsu Maxf Electric Appliance Co., Ltd., CN
IRP
Jul 27, 2023K231912Therm-X
Zenith Technical Innovations
IRP
Jul 19, 2023K231437LF900
Daesung Maref Co., Ltd., KR
IRP
Apr 4, 2023K230385Ballancer Platinum (1222)
Mego Afek, IL
IRP
Mar 15, 2023K222991Air Compression Leg Massager (model: EMK-701)
Xiamen Emoka Health Science & Technology Co., Ltd., CN
IRP
Mar 14, 2023K223464Leg and Foot Air Wave Pressure Therapy Device
Zhangzhou Easepal Innovation CO , Ltd., CN
IRP
Mar 8, 2023K222136Cryo-Thermo Compression Device (FGK002)
Suzhou Microport Rehabtech (Group) Co., Ltd., CN
IRP
Dec 23, 2022K222924Leg Massager RF-ALM070
Shenzhen Ruiyi Business Technology Co., Ltd., CN
IRP
Dec 22, 2022K222949Air Compression Leg Massager (Model: LY-670D)
Zhejiang Luyao Electronics Technology Co., Ltd., CN
IRP
Dec 8, 2022K221862YY-A02-B Overlapped Compression Therapy
Huizhou Xinyi Technology Co., Ltd., CN
IRP

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