Cleared Traditional

K111273 - FIR HEAT THERAPHY SYSYEMS

K111273 is an FDA 510(k) clearance for FIR HEAT THERAPHY SYSYEMS, manufactured by Shenzhen Anpan Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K111273 · Shenzhen Anpan Technology Co., Ltd. · Physical Medicine device
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Nov 2011
Decision
188d
Days
Class 2
Risk

K111273 is an FDA 510(k) clearance for the FIR HEAT THERAPHY SYSYEMS. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Shenzhen Anpan Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 8, 2011 after a review of 188 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Anpan Technology Co., Ltd. devices

FDA 510(k) Submission Details - K111273

510(k) Number K111273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date November 08, 2011
Days to Decision 188 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.