Atlas FDA

IRP

155 FDA 510(k) clearances · Product code

115 daysmedian time to decision
326 days90th percentile
155clearances measured

FDA profile

Official device name
Massager, Powered Inflatable Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5650
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Air Compression Massager (HY-1165) (K260529)Xiamen High Top Electronic Technology Co., Ltd.2026-07-27
Air Compression Massager (EP30B001 I) (K260948)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.2026-07-24
Cryo And Thermo Therapy System (K253919)Xiamen Weiyou Intelligent Technology Co., Ltd.2026-06-10
Cryo Sport 2.0 (AVA 501) (K252396)Avanutri Equipamentos DE Saúde2026-05-29
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) (K254200)Wenzhou Lingfeng Electronic Technology Co., Ltd.2026-05-05
Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) (K253064)Xiamen Weiyou Intelligent Technology Co., Ltd.2026-04-30
Hot and Cold Compression System (A02-C-032) (K252386)Chengdu Cryo-Push Medical Technology Co.,Ltd2026-04-03
Cryopush Cold Compression Device (A02-P-001) (K253076)Chengdu Cryo-Push Medical Technology Co.,Ltd2026-04-02
Hand Massager (SM004D) (K251622)Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.2026-01-28
Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (K251662)Shenzhen Future Electronic Co., Ltd.2025-11-13
AIR COMPRESSION BOOTS 1018195,1018196 (K251531)Merchsource, LLC2025-10-30
Cryon-X Cold Compression (K253150)Jkh Health Co., Ltd.2025-10-24
Normatec Elite Hip (K251905)NormaTec Industries, LP2025-09-18
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (K251623)Shenzhen Yicai Health Technology Co., Ltd.2025-09-17
Compression Therapy Device (LGT-2210DS) (K250244)Guangzhou Longest Medical Technology Co., Ltd.2025-07-25
Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) (K242615)Xiamen Taotao Technology Co., Ltd.2025-07-23
ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (K242754)Zamar Medical D.O.O.2025-05-05
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (K250046)Shenzhen Urion Technology Co., Ltd.2025-04-25
Air Compression Leg Massager (K-705) (K242140)Jiale Health Technology Shenzhen Co., Ltd.2025-03-17
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) (K243206)Sichuan Qianli-Beoka Medical Technology, Inc.2025-02-19
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 Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (K243572)Avanos Medical, Inc.2025-01-31
Air Pressure Therapy System (K243791)Xiamen Weiyou Intelligent Technology Co., Ltd.2025-01-13
SACS PRO (K243177)Elastimed , Ltd.2024-12-23
Leg Massager (Models:RP-ALM070H, RP-ALM071H) (K232965)Shenzhen Ruiyi Business Technology Co., Ltd.2024-11-20
Air Pressure Therapy System (VU-IPC04B) (K243320)Xiamen Weiyou Intelligent Technology Co., Ltd.2024-11-18
Xrecovery (XR-001) (K242940)Shenzhen Xinrun Electric Appliances Co, Ltd.2024-11-14
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) (K241446)Sichuan Qianii-Beoka Medical Technoiogy Lnc.2024-10-08
Air compression Leg Massager (MM0520, MM0521, MM0522) (K240373)Zhangzhou Easepal Medical Science and Technology Co., Ltd.2024-09-17
JetBoots PRO Plus (K241256)Therabody, Inc.2024-08-30
Air compression leg massager (K240981)Huizhou Xinyi Technology Co., Ltd.2024-08-02
Air Pressure Therapy System (Model:VU-IPC4M) (K233238)Xiamen Weiyou Intelligent Technology Co., Ltd.2024-06-14
Cold Compression (K240986)Jkh Health Co., Ltd.2024-05-01
Normatec Elite (K240122)NormaTec Industries, LP2024-03-21
Cold Compression Wrap Pro (K230524)Chengdu Cryo-Push Medical Technology Co.,Ltd2024-01-19
FLOWpresso (K223729)Medella Health Limited2023-12-21
Air Compression Recovery System (K233536)Shenzhen Dongjilian Medical Tech Co., Ltd.2023-12-16
Cold/Hot Compression (K223541)Jkh Health Co., Ltd.2023-10-27
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) (K230500)Jiangsu Maxf Electric Appliance Co., Ltd.2023-10-26
Therm-X (K231912)Zenith Technical Innovations2023-07-27
LF900 (K231437)Daesung Maref Co., Ltd.2023-07-19
Ballancer Platinum (1222) (K230385)Mego Afek2023-04-04
Air Compression Leg Massager (model: EMK-701) (K222991)Xiamen Emoka Health Science & Technology Co., Ltd.2023-03-15
Leg and Foot Air Wave Pressure Therapy Device (K223464)Zhangzhou Easepal Innovation CO , Ltd.2023-03-14
Cryo-Thermo Compression Device (FGK002) (K222136)Suzhou Microport Rehabtech (Group) Co., Ltd.2023-03-08
Leg Massager RF-ALM070 (K222924)Shenzhen Ruiyi Business Technology Co., Ltd.2022-12-23
Air Compression Leg Massager (Model: LY-670D) (K222949)Zhejiang Luyao Electronics Technology Co., Ltd.2022-12-22
YY-A02-B Overlapped Compression Therapy (K221862)Huizhou Xinyi Technology Co., Ltd.2022-12-08
Cryopush Cold Compression Device (K222669)Chengdu Cryo-Push Medical Technology Co.,Ltd2022-12-05
Aquilo Sports CCT1500 System (K223164)Aquilo Sports, LLC2022-11-04
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) (K222206)Shenzhen Dongjilian Medical Tech Co., Ltd.2022-09-30
Powered Inflatable Tube Massager - SLIM UP DRAIN (K201730)Foggiare Technologies, LLC2022-08-22
Normatec Go (K221666)NormaTec Industries, LP2022-07-14
Air Compression Therapy Device, model: ST-502 (K213745)Shenzhen Future Electronic Co., Ltd.2022-03-31
Air Compression Leg Massager (model: FE-7204B) (K211850)Xiamen Healthpal Electronic Co.,Ltd2022-03-03
Normatec 3 (K220217)NormaTec Industries, LP2022-02-25
Air Pressure Foot Massager (K212935)Xiamen Simo Electronic Co., Ltd.2022-02-19
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K213533)Bio Compression Systems, Inc.2022-02-16
Air compression leg massager HY-1117A (K212713)Xiamen High Top Electronic Technology Co., Ltd.2022-01-18
Air compression therapy system FO3002 (K212169)Foshan Hongfeng Co., Ltd.2021-11-23
Air Compression Massager (Model LF-FT003) (K213000)Wenzhou Lingfeng Electronic Technology Co., Ltd.2021-11-15
RecoveryAir PRO (K211745)Theragun, Inc.2021-10-04
Compressible Limb and Circulation Therapy System, Model POWER-Q2300 (K211283)Wonjin Mulsan Co., Ltd.2021-09-14
Air Relax Pro Model AR-4.0 (K212491)Diode Art Engineering Doing Business AS Air Relax2021-09-02
SP-1000, SP-2000 (K202395)Daesung Maref Co., Ltd.2021-09-01
V12 PRO (K210913)Slk Medical GmbH2021-08-04
LX9max (K203498)Daesung Maref Co., Ltd.2021-07-02
Air Pressure Therapy System (K201935)Xiamen Weiyou Intelligent Technology Co., Ltd.2021-06-22
LF900 (K203019)Daesung Maref Co., Ltd.2021-06-22
Fist Assist Devices Model FA-1 (K210281)Fist Assist Devices, LLC2021-06-17
Air Relax Plus Model AR-3.0 (K211460)Diode Art Engineering Doing Business AS Air Relax2021-05-25
Air Pressure Therapy System: VU-IPC06 (K210967)Xiamen Weiyou Intelligent Technology Co., Ltd.2021-05-11
Air compression therapy system FO-3001; Air compression therapy system FO-3008 (K201982)Foshan Hongfeng Co., Ltd.2021-03-25
Compressible Limb and Circulation Therapy System (K200660)Wonjin Mulsan Co., Ltd.2021-03-08
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) (K191441)Maxstar Industrial Co., Ltd.2021-03-05
NeoWave Pain Relief and Recovery System, Model# T16-2020 (K202693)Eva Medtec, Inc.2021-03-05
Air Compression Therapy Device, model HW6007 (K210240)Konliking Tech & Dev. Limited2021-02-22
ICE COMPRESSION FIRST, DUO, & MOOVE Systems (K193079)Mks Paris2021-01-11
Rapid Reboot (K203552)Rapid Reboot Recovery Products, LLC2020-12-22
Air Compression Therapy Device (K201694)Shenzhen Dongjilian Electronics Co., Ltd.2020-11-19
Powerpress Recovery Unit (K202044)Hanuri Distribution, Inc.2020-10-21
Massage Compression Boots (K201645)Jkh USA, LLC2020-09-15
PlasmaFlight (K200351)Manamed, Inc.2020-08-05
Air Compression Therapy System (K192466)Shenzhen Lifotronic Technology Co., Ltd.2020-06-22
Air Compression Therapy Device (K193354)Shenzhen Dongjilian Electronics Co., Ltd.2020-06-08
Pressure Therapy System PT1003 (K192358)Xiamen Senyang Co., Ltd.2020-04-23
Therm-X (K193550)Zenith Technical Innovations2020-02-28
LiteWalk (K192607)Viasonix , Ltd.2019-12-19
Compression Therapy Device Model LGT-2200SP (K191862)Guangzhou Longest Science & Technology Co., Ltd.2019-10-29
Game Ready GRPro 2.1 System (K192114)Cool Systems, Inc. (Dba Game Ready)2019-10-29
ProPerformance Recovery System (K192252)Menlo Brands, LLC2019-09-19
Air Relax (K173158)Maxstar Industrial Co., Ltd.2019-05-30
Recovery Pump, 737R (RPX) (K190493)Mego Afek AC , Ltd.2019-05-15
Therm-X (K190854)Zenith Technical Innovations2019-05-10
Ballancer Gold, 1212 (K190015)Mego Afek AC , Ltd.2019-03-25
Polar Care Wave (K183702)Breg, Inc.2019-03-01
Pressure Therapy System PT1003 (K181409)Xiamen Senyang Co., Ltd.2019-02-19
Pulse 2.0, Pulse Pro 2.0 (K183169)NormaTec Industries, LP2018-12-27
Rapid Reboot Compression Therapy System (K182668)Rapid Reboot Recovery Products, LLC2018-12-14
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (K181149)Zenith Technical Innovations2018-08-03
Med4 Elite (K171685)Cool Systems, Inc. (Dba Game Ready)2017-09-29
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