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510(k) Data Aggregation
K Number
K033555Device Name
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
Manufacturer
Date Cleared
2004-03-02
(111 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
KAYLIGHT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Device Description
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