Cleared Traditional

K053376 - CHUNG CHENG FAR INFRARED RAY HEALTHFUL ...

K053376 is an FDA 510(k) clearance for CHUNG CHENG FAR INFRARED RAY HEALTHFUL ..., manufactured by Chung Cheng Electric Heating Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K053376 · Chung Cheng Electric Heating Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
73d
Days
Class 2
Risk

K053376 is an FDA 510(k) clearance for the CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL .... Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Chung Cheng Electric Heating Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on February 16, 2006 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chung Cheng Electric Heating Co., Ltd. devices

FDA 510(k) Submission Details - K053376

510(k) Number K053376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date February 16, 2006
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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

All 28
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