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510(k) Data Aggregation
K Number
K052492Device Name
AIRNERGY+STREAM
Manufacturer
Date Cleared
2006-09-05
(358 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
NATURAL ENERGY SOLUTIONS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AIRNERGY+® Stream is indicated for use to emit energy to provide topical heating for the purposes of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary relief of minor arthritis pain and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where applied.
Device Description
Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology. The device electrical and mechanical design is for use and convenience of the users. The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm.
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