JOW
- 产品代码
- JOW
- 器械名称
- Sleeve, Limb, Compressible
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.5800
- FDA 专业组
- Cardiovascular
- 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)
- 21 件
- 其中 Summary 已存档
- 14 份，可直接下载
- FDA 历史累计 510(k)
- 352 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)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253555 | 2026-07-31 | Tactile Medical | Flexitouch® Plus Advanced Pneumatic Compression Syst… | |
| K253386 | 2026-06-25 | Vistar Medical Supplies Co., Ltd. | DVT Garment | |
| K250242 | 2026-04-24 | Guangzhou Longest Medical Technology C… | Compression Therapy Device (LGT-2202DVT) | |
| K254267 | 2026-02-24 | Mego Afek , Ltd. | NanoPress 760A-BT (760A-BT) | — |
| K250974 | 2025-12-12 | Bio Compression Systems, Inc. | Bio Arterial Deluxe (IC-BAP-DX) | |
| K250190 | 2025-12-08 | Shenzhen Comen Medical Instruments Co.… | Sequential Compression System (SCD600) | |
| K251466 | 2025-10-28 | Wellell, Inc. | VenAir, Sequential Compression System (9P-089000); V… | |
| K251446 | 2025-09-17 | Manamed, LLC | PlasmaFlow X Compression Sleeve Device (XPF0001) | — |
| K251086 | 2025-08-18 | Biotab, LLC | PnueAira (PNCU-01) | |
| K250817 | 2025-08-08 | Vive Health, LLC | Coretech Compression System (Coretech RHB3003) | |
| K241096 | 2025-01-15 | Suzhou Minhua Medical Apparatus Suppli… | Venera 608 Deep Vein Thrombosis (DVT) Prevention Sys… | |
| K240499 | 2024-10-11 | Airos Medical, Inc. | ARTAIRA Arterial Compression Device (AACD01) | |
| K241746 | 2024-10-04 | United Medical Resources, LLC | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED RE… | — |
| K232640 | 2024-06-25 | Thermabright | Venowave VW5 | FDA |
| K240125 | 2024-06-21 | Zenith Technical Innovations | Therm-X (Home); Therm-X (AT) | |
| K234155 | 2024-06-21 | Tactile Medical | Nimbl (model PD08-N1) | FDA |
| K232270 | 2024-03-06 | Koge Micro Tech Co., Ltd. | DVT Motion Pneumatic Compression Device | |
| K240011 | 2024-02-23 | Jkh Health Co., Ltd. | Lymphedema Compression | |
| K223228 | 2024-01-04 | Koya Medical, Inc. | Dayspring | |
| K232300 | 2023-12-22 | Elastimed , Ltd. | ElastiMed SACS | FDA |
| K231801 | 2023-12-14 | Medhealth Medical Limited | MedHealth DVT compression Devices MHH900S/MHH900E | FDA |
FDA 官方分类页： JOW
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。