FDA.report

510(k) K252861

Device
Warming System
Applicant
Hangzhou Tappa Medical Technology Co., Ltd.
510(k) number
K252861
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-07
Date received
2025-09-09
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Na Ban
Address
# 225#, Chutian Rd., Binjiang District, Hangzhou Hangzhou CN

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K231596IOB Temperature Management SystemIob Medical, Inc.2023-06-30
K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2023-06-29
K221669IOB Warming BlanketsIob Medical, Inc.2022-12-27
K220941HotDog Temperature Management SystemAugustine Temperature Management2022-09-23
K2106053M Bair Hugger Universal Warming Gown made with Thinsulate Insulation3M Company2021-04-29