IRP
- 产品代码
- IRP
- 器械名称
- Massager, Powered Inflatable Tube
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.5650
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 39 件
- 其中 Summary 已存档
- 27 份，可直接下载
- FDA 历史累计 510(k)
- 156 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（39 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260944 | 2026-08-12 | Manamed, LLC | ManaCold Compression System | — |
| K260529 | 2026-07-27 | Xiamen High Top Electronic Technology … | Air Compression Massager (HY-1165) | |
| K260948 | 2026-07-24 | Wavepulse (Xiamen) Healthcare Technolo… | Air Compression Massager (EP30B001 I) | |
| K253919 | 2026-06-10 | Xiamen Weiyou Intelligent Technology C… | Cryo And Thermo Therapy System | |
| K252396 | 2026-05-29 | Avanutri Equipamentos DE Saúde | Cryo Sport 2.0 (AVA 501) | |
| K254200 | 2026-05-05 | Wenzhou Lingfeng Electronic Technology… | Air Compression Leg Massager (LF-FT001, LF-FT002-1, … | |
| K253064 | 2026-04-30 | Xiamen Weiyou Intelligent Technology C… | Air Pressure Therapy System (VU-IPC8M); Air Pressure… | |
| K252386 | 2026-04-03 | Chengdu Cryo-Push Medical Technology C… | Hot and Cold Compression System (A02-C-032) | FDA |
| K253076 | 2026-04-02 | Chengdu Cryo-Push Medical Technology C… | Cryopush Cold Compression Device (A02-P-001) | |
| K251622 | 2026-01-28 | Ningbo Zhenhai Yihao Electronic Techno… | Hand Massager (SM004D) | |
| K251662 | 2025-11-13 | Shenzhen Future Electronic Co., Ltd. | Air Compression Therapy Device (ST-504); Air Compres… | |
| K251531 | 2025-10-30 | Merchsource, LLC | AIR COMPRESSION BOOTS 1018195,1018196 | FDA |
| K253150 | 2025-10-24 | Jkh Health Co., Ltd. | Cryon-X Cold Compression | |
| K251905 | 2025-09-18 | NormaTec Industries, LP | Normatec Elite Hip | |
| K251623 | 2025-09-17 | Shenzhen Yicai Health Technology Co., … | Air Compression Therapy Device (K1002/K1006/K1007/K1… | — |
| K250244 | 2025-07-25 | Guangzhou Longest Medical Technology C… | Compression Therapy Device (LGT-2210DS) | |
| K242615 | 2025-07-23 | Xiamen Taotao Technology Co., Ltd. | Intermittent pressure compression system (Compressio… | FDA |
| K242754 | 2025-05-05 | Zamar Medical D.O.O. | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (M… | |
| K250046 | 2025-04-25 | Shenzhen Urion Technology Co., Ltd. | Air Compression Leg Massager (UM605, UM606, UM607, U… | |
| K242140 | 2025-03-17 | Jiale Health Technology Shenzhen Co., … | Air Compression Leg Massager (K-705) | |
| K243206 | 2025-02-19 | Sichuan Qianli-Beoka Medical Technolog… | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, … | |
| K243572 | 2025-01-31 | Avanos Medical, Inc. | Game Ready system (550500-04); Game Ready Control U… | — |
| K243791 | 2025-01-13 | Xiamen Weiyou Intelligent Technology C… | Air Pressure Therapy System | — |
| K243177 | 2024-12-23 | Elastimed , Ltd. | SACS PRO | |
| K232965 | 2024-11-20 | Shenzhen Ruiyi Business Technology Co.… | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | |
| K243320 | 2024-11-18 | Xiamen Weiyou Intelligent Technology C… | Air Pressure Therapy System (VU-IPC04B) | — |
| K242940 | 2024-11-14 | Shenzhen Xinrun Electric Appliances Co… | Xrecovery (XR-001) | |
| K241446 | 2024-10-08 | Sichuan Qianii-Beoka Medical Technoiog… | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, AC… | FDA |
| K240373 | 2024-09-17 | Zhangzhou Easepal Medical Science and … | Air compression Leg Massager (MM0520, MM0521, MM0522… | — |
| K241256 | 2024-08-30 | Therabody, Inc. | JetBoots PRO Plus | |
| K240981 | 2024-08-02 | Huizhou Xinyi Technology Co., Ltd. | Air compression leg massager | — |
| K233238 | 2024-06-14 | Xiamen Weiyou Intelligent Technology C… | Air Pressure Therapy System (Model:VU-IPC4M) | |
| K240986 | 2024-05-01 | Jkh Health Co., Ltd. | Cold Compression | |
| K240122 | 2024-03-21 | NormaTec Industries, LP | Normatec Elite | |
| K230524 | 2024-01-19 | Chengdu Cryo-Push Medical Technology C… | Cold Compression Wrap Pro | |
| K223729 | 2023-12-21 | Medella Health Limited | FLOWpresso | |
| K233536 | 2023-12-16 | Shenzhen Dongjilian Medical Tech Co., … | Air Compression Recovery System | — |
| K223541 | 2023-10-27 | Jkh Health Co., Ltd. | Cold/Hot Compression | |
| K230500 | 2023-10-26 | Jiangsu Maxf Electric Appliance Co., L… | Air Compression Therapy Recovery System (model: MF-A… |
FDA 官方分类页： IRP
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。