Disposable Warming Blanket— 510(k) K262089
Substantially EquivalentHangzhou Tappa Medical Technology Co., Ltd.
FDA 510(k) clearance K262089 for Disposable Warming Blanket, Substantially Equivalent on 2026-08-21. Applicant: Hangzhou Tappa Medical Technology Co., Ltd.. Device class: 2.
Summary
Hangzhou Tappa Medical Technology filed a Disposable Warming Blanket under product code DWJ, thermal regulating systems. The device name is generic, and the record lists no model numbers.
Class II, 21 CFR 870.5900. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
Tappa filed from Hangzhou, China. The decision came 60 calendar days after FDA received it (June 22 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Hangzhou Tappa Medical Technology Co., Ltd.
- Product code
- Product code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code DWJ
view allMore clearances from Hangzhou Tappa Medical Technology Co., Ltd.
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.