FIR HEAT THERAPHY SYSYEMS— 510(k) K111273

Substantially Equivalent

Shenzhen Anpan Technology Co., Ltd.

FDA 510(k) clearance K111273 for FIR HEAT THERAPHY SYSYEMS, Substantially Equivalent on 2011-11-08. Applicant: Shenzhen Anpan Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shenzhen Anpan Technology Co., Ltd.
Product code
Code IRT
Device class
Class 2
Regulation
21 CFR 890.5740
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, CN
Download summary PDFView on FDA.gov ↗

Recent devices under product code IRT

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Adverse events under product code IRT

product code IRT
Injury
668
Total
668

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.