Intended Use

Intended Use & Indications

U.S. FDA-Clearance: The AVACEN 100 is a non-invasive class II medical device that is cleared by the FDA as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; 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.

E.U. CE Mark Approval: A heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; the temporary relief of widespread pain associated with fibromyalgia; muscular relaxation; and the temporary increase of microcirculation.

IMPORTANT: The AVACEN 100 is not for sale in the U.S. or E.U. for any non-cleared or non-approved indications. For more details on Contraindications, Warnings and Precautions, please view the AVACEN 100 User Guide.