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510(k) Data Aggregation
K Number
K053376Device Name
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810
Manufacturer
Date Cleared
2006-02-16
(73 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
CHUNG CHENG ELECTRIC HEATING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Device Description
The "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 can be used to emit topical heating to the body of human. The device make use of a "All In One" Automatic control Temperature Ceramic Semiconductor. Emission spectrum ranges from 4 to 14 microns. The device uses 120Vac as power source & 800W . it meets the related requirement of IEC 60601-1 Electrical Safety.
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