510(k) clearance

Disposable Warming Blanket

FDA 510(k) source

510(k) number

K262089

Applicant

Hangzhou Tappa Medical Technology Co., Ltd.

Decision date

Aug 21, 2026

Date received

Jun 22, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DWJ

Device type

System, Thermal Regulating

Device class

Class II

Regulation

21 CFR 870.5900

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Hangzhou, CN