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 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260944 | ManaCold Compression System | Manamed, LLC | 2026-08-12 | Traditional | PDF ↗ |
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | 2026-07-27 | Traditional | PDF ↗ |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-06-10 | Traditional | PDF ↗ |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | 2026-05-29 | Traditional | PDF ↗ |
| K254200 | 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) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2026-05-05 | Traditional | PDF ↗ |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-04-30 | Traditional | PDF ↗ |
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-03 | Traditional | PDF ↗ |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2026-04-02 | Traditional | PDF ↗ |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | 2026-01-28 | Traditional | PDF ↗ |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. | 2025-11-13 | Traditional | PDF ↗ |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | 2025-10-30 | Traditional | PDF ↗ |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025-10-24 | Special | PDF ↗ |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 2025-09-18 | Traditional | PDF ↗ |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | 2025-09-17 | Traditional | PDF ↗ |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-07-25 | Traditional | PDF ↗ |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. | 2025-07-23 | Traditional | PDF ↗ |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | 2025-05-05 | Traditional | PDF ↗ |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | 2025-04-25 | Traditional | PDF ↗ |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | 2025-03-17 | Traditional | PDF ↗ |
| K243206 | Air 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. | 2025-02-19 | Traditional | PDF ↗ |
| K243572 | 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 | Avanos Medical, Inc. | 2025-01-31 | Special | PDF ↗ |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2025-01-13 | Special | PDF ↗ |
| K243177 | SACS PRO | Elastimed , Ltd. | 2024-12-23 | Traditional | PDF ↗ |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024-11-20 | Traditional | PDF ↗ |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-11-18 | Special | PDF ↗ |
| K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. | 2024-11-14 | Traditional | PDF ↗ |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | 2024-10-08 | Traditional | PDF ↗ |
| K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2024-09-17 | Traditional | PDF ↗ |
| K241256 | JetBoots PRO Plus | Therabody, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K240981 | Air compression leg massager | Huizhou Xinyi Technology Co., Ltd. | 2024-08-02 | Traditional | PDF ↗ |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K240986 | Cold Compression | Jkh Health Co., Ltd. | 2024-05-01 | Special | PDF ↗ |
| K240122 | Normatec Elite | NormaTec Industries, LP | 2024-03-21 | Traditional | PDF ↗ |
| K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024-01-19 | Traditional | PDF ↗ |
| K223729 | FLOWpresso | Medella Health Limited | 2023-12-21 | Traditional | PDF ↗ |
| K233536 | Air Compression Recovery System | Shenzhen Dongjilian Medical Tech Co., Ltd. | 2023-12-16 | Traditional | PDF ↗ |
| K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023-10-27 | Traditional | PDF ↗ |
| K230500 | 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) | Jiangsu Maxf Electric Appliance Co., Ltd. | 2023-10-26 | Traditional | PDF ↗ |
| K231912 | Therm-X | Zenith Technical Innovations | 2023-07-27 | Special | PDF ↗ |
| K231437 | LF900 | Daesung Maref Co., Ltd. | 2023-07-19 | Special | PDF ↗ |
| K230385 | Ballancer Platinum (1222) | Mego Afek | 2023-04-04 | Traditional | PDF ↗ |
| K222991 | Air Compression Leg Massager (model: EMK-701) | Xiamen Emoka Health Science & Technology Co., Ltd. | 2023-03-15 | Traditional | PDF ↗ |
| K223464 | Leg and Foot Air Wave Pressure Therapy Device | Zhangzhou Easepal Innovation CO , Ltd. | 2023-03-14 | Traditional | PDF ↗ |
| K222136 | Cryo-Thermo Compression Device (FGK002) | Suzhou Microport Rehabtech (Group) Co., Ltd. | 2023-03-08 | Traditional | PDF ↗ |
| K222924 | Leg Massager RF-ALM070 | Shenzhen Ruiyi Business Technology Co., Ltd. | 2022-12-23 | Traditional | PDF ↗ |
| K222949 | Air Compression Leg Massager (Model: LY-670D) | Zhejiang Luyao Electronics Technology Co., Ltd. | 2022-12-22 | Traditional | PDF ↗ |
| K221862 | YY-A02-B Overlapped Compression Therapy | Huizhou Xinyi Technology Co., Ltd. | 2022-12-08 | Traditional | PDF ↗ |
| K222669 | Cryopush Cold Compression Device | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2022-12-05 | Traditional | PDF ↗ |
| K223164 | Aquilo Sports CCT1500 System | Aquilo Sports, LLC | 2022-11-04 | Traditional | PDF ↗ |
| K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) | Shenzhen Dongjilian Medical Tech Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K201730 | Powered Inflatable Tube Massager - SLIM UP DRAIN | Foggiare Technologies, LLC | 2022-08-22 | Traditional | PDF ↗ |
| K221666 | Normatec Go | NormaTec Industries, LP | 2022-07-14 | Traditional | PDF ↗ |
| K213745 | Air Compression Therapy Device, model: ST-502 | Shenzhen Future Electronic Co., Ltd. | 2022-03-31 | Traditional | PDF ↗ |
| K211850 | Air Compression Leg Massager (model: FE-7204B) | Xiamen Healthpal Electronic Co.,Ltd | 2022-03-03 | Traditional | PDF ↗ |
| K220217 | Normatec 3 | NormaTec Industries, LP | 2022-02-25 | Traditional | PDF ↗ |
| K212935 | Air Pressure Foot Massager | Xiamen Simo Electronic Co., Ltd. | 2022-02-19 | Traditional | PDF ↗ |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | 2022-02-16 | Traditional | PDF ↗ |
| K212713 | Air compression leg massager HY-1117A | Xiamen High Top Electronic Technology Co., Ltd. | 2022-01-18 | Traditional | PDF ↗ |
| K212169 | Air compression therapy system FO3002 | Foshan Hongfeng Co., Ltd. | 2021-11-23 | Traditional | PDF ↗ |
| K213000 | Air Compression Massager (Model LF-FT003) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 2021-11-15 | Traditional | PDF ↗ |
| K211745 | RecoveryAir PRO | Theragun, Inc. | 2021-10-04 | Traditional | PDF ↗ |
| K211283 | Compressible Limb and Circulation Therapy System, Model POWER-Q2300 | Wonjin Mulsan Co., Ltd. | 2021-09-14 | Traditional | PDF ↗ |
| K212491 | Air Relax Pro Model AR-4.0 | Diode Art Engineering Doing Business AS Air Relax | 2021-09-02 | Traditional | PDF ↗ |
| K202395 | SP-1000, SP-2000 | Daesung Maref Co., Ltd. | 2021-09-01 | Traditional | PDF ↗ |
| K210913 | V12 PRO | Slk Medical GmbH | 2021-08-04 | Traditional | PDF ↗ |
| K203498 | LX9max | Daesung Maref Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K201935 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-06-22 | Traditional | PDF ↗ |
| K203019 | LF900 | Daesung Maref Co., Ltd. | 2021-06-22 | Traditional | PDF ↗ |
| K210281 | Fist Assist Devices Model FA-1 | Fist Assist Devices, LLC | 2021-06-17 | Traditional | PDF ↗ |
| K211460 | Air Relax Plus Model AR-3.0 | Diode Art Engineering Doing Business AS Air Relax | 2021-05-25 | Traditional | PDF ↗ |
| K210967 | Air Pressure Therapy System: VU-IPC06 | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2021-05-11 | Traditional | PDF ↗ |
| K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008 | Foshan Hongfeng Co., Ltd. | 2021-03-25 | Traditional | PDF ↗ |
| K200660 | Compressible Limb and Circulation Therapy System | Wonjin Mulsan Co., Ltd. | 2021-03-08 | Traditional | PDF ↗ |
| K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | Maxstar Industrial Co., Ltd. | 2021-03-05 | Traditional | PDF ↗ |
| K202693 | NeoWave Pain Relief and Recovery System, Model# T16-2020 | Eva Medtec, Inc. | 2021-03-05 | Traditional | PDF ↗ |
| K210240 | Air Compression Therapy Device, model HW6007 | Konliking Tech & Dev. Limited | 2021-02-22 | Traditional | PDF ↗ |
| K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | Mks Paris | 2021-01-11 | Traditional | PDF ↗ |
| K203552 | Rapid Reboot | Rapid Reboot Recovery Products, LLC | 2020-12-22 | Traditional | PDF ↗ |
| K201694 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020-11-19 | Traditional | PDF ↗ |
| K202044 | Powerpress Recovery Unit | Hanuri Distribution, Inc. | 2020-10-21 | Traditional | PDF ↗ |
| K201645 | Massage Compression Boots | Jkh USA, LLC | 2020-09-15 | Traditional | PDF ↗ |
| K200351 | PlasmaFlight | Manamed, Inc. | 2020-08-05 | Traditional | PDF ↗ |
| K192466 | Air Compression Therapy System | Shenzhen Lifotronic Technology Co., Ltd. | 2020-06-22 | Traditional | PDF ↗ |
| K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020-06-08 | Traditional | PDF ↗ |
| K192358 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | 2020-04-23 | Traditional | PDF ↗ |
| K193550 | Therm-X | Zenith Technical Innovations | 2020-02-28 | Traditional | PDF ↗ |
| K192607 | LiteWalk | Viasonix , Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K192114 | Game Ready GRPro 2.1 System | Cool Systems, Inc. (Dba Game Ready) | 2019-10-29 | Traditional | PDF ↗ |
| K191862 | Compression Therapy Device Model LGT-2200SP | Guangzhou Longest Science & Technology Co., Ltd. | 2019-10-29 | Traditional | PDF ↗ |
| K192252 | ProPerformance Recovery System | Menlo Brands, LLC | 2019-09-19 | Traditional | PDF ↗ |
| K173158 | Air Relax | Maxstar Industrial Co., Ltd. | 2019-05-30 | Special | PDF ↗ |
| K190493 | Recovery Pump, 737R (RPX) | Mego Afek AC , Ltd. | 2019-05-15 | Traditional | PDF ↗ |
| K190854 | Therm-X | Zenith Technical Innovations | 2019-05-10 | Abbreviated | PDF ↗ |
| K190015 | Ballancer Gold, 1212 | Mego Afek AC , Ltd. | 2019-03-25 | Traditional | PDF ↗ |
| K183702 | Polar Care Wave | Breg, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K181409 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | 2019-02-19 | Traditional | PDF ↗ |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018-12-27 | Traditional | PDF ↗ |
| K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018-12-14 | Traditional | PDF ↗ |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018-08-03 | Traditional | PDF ↗ |
Product code IRP · Class II · Physical Medicine. Data: openFDA.