Are the AVACEN 100 and the AVACEN Pro devices FDA 510(k) Cleared?

The AVACEN 100 and Pro are Class II Medical Device cleared by the US Food & Drug Administration. They are sold only in the United States as heat therapy system indicated for the temporary relief of minor muscle, joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and minor sprains; muscular relaxation; and the temporary increase in local circulation where applied. The AVACEN 100-E and PRO-E devices are not cleared or registered with the FDA in any way; however, carry the European Union CE Mark.