510(k) clearances

Disposable Warming Blanket

Hangzhou Tappa Medical Technology Co., Ltd. · Cardiovascular

K262089Substantially EquivalentTraditionalDWJ
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
Cardiovascular
Address 1
Rm. 2002, Bldg. 1, Chutian Technology Bldg., # 225 Chutian R
Statement or summary
Summary
Product code
DWJ
Applicant
Hangzhou Tappa Medical Technology Co., Ltd.
Decision date
2026-08-21
Decision code
SESE
Country code
CN
Device name
Disposable Warming Blanket
Advisory committee
CV
Contact
Dan Cao
K number
K262089
Date received
2026-06-22
Review advisory committee
CV
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Thermal Regulating
Medical specialty description
Cardiovascular
Regulation number
870.5900
Device class
2
Registration number
3009093866, 1417592, 9617604, 3030597679, 3032911850, 3016844398, 3004491421, 3005997949, 2133786, 1219702, 3012689738, 3005238200, 1043644, 3006240053, 3008727520, 3043226252, 3012315097, 3010476117, 3011059079, 3041276890, 1018233, 3031841433, 3005941719, 1725056, 8022590, 3016114530, 2183613, 3014263632, 3013410562, 2133810, 2320762, 3003857828, 3012494290, 3038241934, 3016507522, 1000122786, 1055236, 9610849, 3007616088, 3010380518 +54 more
FEI number
3009093866, 1417592, 1000117260, 3030597679, 3032911850, 3016844398, 3004491421, 3005997949, 1219702, 3003329224, 3012689738, 3005238200, 3003807323, 1000112877, 1043644, 1000160458, 3006240053, 3003753496, 3008727520, 3043226252, 3012315097, 3010476117, 1000221205, 3011059079, 3041276890, 1018233, 3031841433, 1000521377, 3016114530, 2183613, 3014263632, 3013410562, 3002809016, 3003857828, 3012494290, 3038241934, 3016507522, 3495, 3007513035, 3003261020 +54 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.