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)
- 156 件
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 |
|---|---|---|---|
| K260944 | 2026-08-12 | Manamed, LLC | ManaCold Compression System |
| K260529 | 2026-07-27 | Xiamen High Top Electronic Technology | Air Compression Massager (HY-1165) 摘要 |
| K260948 | 2026-07-24 | Wavepulse (Xiamen) Healthcare Technolo | Air Compression Massager (EP30B001 I) 摘要 |
| K253919 | 2026-06-10 | Xiamen Weiyou Intelligent Technology C | Cryo And Thermo Therapy System 摘要 |
| K252396 | 2026-05-29 | Avanutri Equipamentos DE Saúde | Cryo Sport 2.0 (AVA 501) 摘要 |
| K254200 | 2026-05-05 | Wenzhou Lingfeng Electronic Technology | Air Compression Leg Massager (LF-FT001, LF-FT002-1, 摘要 |
| K253064 | 2026-04-30 | Xiamen Weiyou Intelligent Technology C | Air Pressure Therapy System (VU-IPC8M); Air Pressure 摘要 |
| K252386 | 2026-04-03 | Chengdu Cryo-Push Medical Technology C | Hot and Cold Compression System (A02-C-032) 摘要 |
| K253076 | 2026-04-02 | Chengdu Cryo-Push Medical Technology C | Cryopush Cold Compression Device (A02-P-001) 摘要 |
| K251622 | 2026-01-28 | Ningbo Zhenhai Yihao Electronic Techno | Hand Massager (SM004D) 摘要 |
| K251662 | 2025-11-13 | Shenzhen Future Electronic Co., Ltd. | Air Compression Therapy Device (ST-504); Air Compres 摘要 |
| K251531 | 2025-10-30 | Merchsource, LLC | AIR COMPRESSION BOOTS 1018195,1018196 摘要 |
| K253150 | 2025-10-24 | Jkh Health Co., Ltd. | Cryon-X Cold Compression 摘要 |
| K251905 | 2025-09-18 | NormaTec Industries, LP | Normatec Elite Hip 摘要 |
| 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) 摘要 |
| K242615 | 2025-07-23 | Xiamen Taotao Technology Co., Ltd. | Intermittent pressure compression system (Compressio 摘要 |
| K242754 | 2025-05-05 | Zamar Medical D.O.O. | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (M 摘要 |
| K250046 | 2025-04-25 | Shenzhen Urion Technology Co., Ltd. | Air Compression Leg Massager (UM605, UM606, UM607, U 摘要 |
| K242140 | 2025-03-17 | Jiale Health Technology Shenzhen Co., | Air Compression Leg Massager (K-705) 摘要 |
| K243206 | 2025-02-19 | Sichuan Qianli-Beoka Medical Technolog | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, 摘要 |
| 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 摘要 |
| K232965 | 2024-11-20 | Shenzhen Ruiyi Business Technology Co. | Leg Massager (Models:RP-ALM070H, RP-ALM071H) 摘要 |
| 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) 摘要 |
| K241446 | 2024-10-08 | Sichuan Qianii-Beoka Medical Technoiog | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, AC 摘要 |
| 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 摘要 |
| 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) 摘要 |
| K240986 | 2024-05-01 | Jkh Health Co., Ltd. | Cold Compression 摘要 |
| K240122 | 2024-03-21 | NormaTec Industries, LP | Normatec Elite 摘要 |
| K230524 | 2024-01-19 | Chengdu Cryo-Push Medical Technology C | Cold Compression Wrap Pro 摘要 |
| K223729 | 2023-12-21 | Medella Health Limited | FLOWpresso 摘要 |
| K233536 | 2023-12-16 | Shenzhen Dongjilian Medical Tech Co., | Air Compression Recovery System |
| K223541 | 2023-10-27 | Jkh Health Co., Ltd. | Cold/Hot Compression 摘要 |
| K230500 | 2023-10-26 | Jiangsu Maxf Electric Appliance Co., L | Air Compression Therapy Recovery System (model: MF-A 摘要 |
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。