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510(k) Data Aggregation
K Number
K133981Device Name
AVACEN 100
Manufacturer
AVACEN INC.
Date Cleared
2014-08-15
(232 days)
Product Code
IRT
Regulation Number
890.5740Why did this record match?
Applicant Name (Manufacturer) :
AVACEN INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
Device Description
The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
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