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510(k) Data Aggregation
K Number
K060134Device Name
APOLLO IR HEAT LAMP SYSTEM
Manufacturer
Date Cleared
2006-03-21
(62 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Device Description
The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
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