DWJ
- 产品代码
- DWJ
- 器械名称
- System, Thermal Regulating
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.5900
- 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)
- 161 件
FDA 分类定义
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262089 | 2026-08-21 | Hangzhou Tappa Medical Technology Co., | Disposable Warming Blanket 摘要 |
| K261437 | 2026-08-07 | The Surgical Company International B.V | Mistral-Air® Warming System 摘要 |
| K260278 | 2026-07-08 | Stihler Electronic GmbH | ThermAffyx(TM) Patient Safety System 摘要 |
| K260903 | 2026-04-16 | Xodus Medical, Inc. | Hot Pink Pad Warming System 摘要 |
| K252861 | 2026-04-07 | Hangzhou Tappa Medical Technology Co., | Warming System 摘要 |
| K251974 | 2025-10-24 | Medivance, Inc. | Arctic Sun Temperature Management System (Model 5000 摘要 |
| K242964 | 2025-06-20 | Hadleigh Health Technologies | Celsi Warmer 摘要 |
| K243942 | 2025-04-30 | Medivance, Inc. | Arctic Sun Stat Temperature Management System 摘要 |
| K232627 | 2024-04-18 | Augustine Temperature Management, LLC | HotDog Warming Mattress + Return Electrode 摘要 |
| K232502 | 2024-02-21 | Care Essentials Pty, Ltd. | Cocoon Convective Warming System, Model CWS7000 摘要 |
| K231211 | 2023-12-01 | Medline Industries, LP | Medline ComfortTemp Patient Warming System 摘要 |
| K232638 | 2023-10-24 | Iob Medical, Inc. | FilteredFlo Warming Blankets 摘要 |
| K232844 | 2023-10-04 | Braincool AB | The IQoolTM System 摘要 |
| K232508 | 2023-09-15 | Molnlycke Health Care Us, LLC | Barrier EasyWarm Active Self-Warming Blanket 摘要 |
FDA 官方分类页： DWJ
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。