FDA.reportPublic FDA data

510(k) K262089

Device
Disposable Warming Blanket
Applicant
Hangzhou Tappa Medical Technology Co., Ltd.
510(k) number
K262089
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-21
Date received
2026-06-22
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Dan Cao
Address
Rm. 2002, Bldg. 1, Chutian Technology Bldg., # 225 Chutian R Hangzhou CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life2026-08-07
K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH2026-07-08
K260903Hot Pink Pad Warming SystemXodus Medical, Inc.2026-04-16
K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.2026-04-07
K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.2025-10-24
K242964Celsi WarmerHadleigh Health Technologies2025-06-20
K243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.2025-04-30
K232627HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2024-04-18
K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.2024-02-21
K231211Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-01
K232638FilteredFlo Warming BlanketsIob Medical, Inc.2023-10-24
K232844The IQoolTM SystemBraincool AB2023-10-04
K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2023-09-15
K231596IOB Temperature Management SystemIob Medical, Inc.2023-06-30
K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2023-06-29