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510(k) Data Aggregation
K Number
K051046Device Name
PAINACEA MODEL XR8 INFRARED HEAT LAMP
Manufacturer
Date Cleared
2005-05-10
(15 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ATLANTIS LUMINESCENT PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Device Description
The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.
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