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510(k) Data Aggregation
K Number
K012508Device Name
MU PHOTONICS PAIN THERAPIST
Manufacturer
Date Cleared
2001-10-09
(64 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
NU PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This unit may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This unit may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Device Description
The Nu Photonics Pain Therapist consists of a collection of both infrared and red diodes packaged in a compact plastic case. The system emits pulsed light in the infrared spectrum to provide topical heating, arranged in an area covering just over 11 square inches. The red diodes provide a visible indication that the unit is in operation. The system incorporates an "Auto Off" feature, in the event that the user may inadvertently leave the device on.
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