Cleared Traditional

K043558 - XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A

K043558 is an FDA 510(k) clearance for XINFENG HEAT LAMPS, manufactured by Chongqing Xinfeng Medical Instruments Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K043558 · Chongqing Xinfeng Medical Instruments Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
161d
Days
Class 2
Risk

K043558 is an FDA 510(k) clearance for the XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Chongqing Xinfeng Medical Instruments Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 161 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 Chongqing Xinfeng Medical Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K043558

510(k) Number K043558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date June 06, 2005
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

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