AVACEN FDA Clearance

AVACEN Medical Device

On October 22, 2014, AVACEN Medical of San Diego announced that its AVACEN 100 Class II medical device received 510 (k) OTC clearance by the U.S. Food and Drug Administration.This clearance allows the AVACEN 100 to be marketed over the Internet for: the temporary relief of joint pain associated with arthritis; muscle spasms; and minor strains and sprains.

The original press release reads:

The AVACEN 100 is a sophisticated medical device incorporating over 3,000 firmware instructions supporting numerous innovations including an internal ‘Game Mode.’ This mode encourages users to complete their 10-30 minute therapy session, and also allows a therapist to monitor for proper device use during self-administered therapy.

AVACEN FDA clearence

[ FDA Clearance ]