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510(k) Data Aggregation
K Number
K024027Device Name
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
Manufacturer
Date Cleared
2003-12-03
(362 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
SKYTECH ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
Device Description
The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength.
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