HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.

Reason: Products are marketed without a cleared 510k.

Code information: All lots; UPC: 862821000030.

Distribution pattern: Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.