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510(k) Data Aggregation
K Number
K081505Device Name
THERAGEM PROFESSIONAL T1002
Manufacturer
Date Cleared
2008-11-19
(174 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
MEDICA HEALTH, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp indicated for adjunctive use and providing temporary relief of minor muscle and joint pain. This device helps to temporarily increase local blood circulation where applied.
Device Description
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device.
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