FDA-Device2016-07-13Class II
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Ergoactives, Llc
Hazard
Products are marketed without a cleared 510k.
Sold states
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.
Affected count
278 units
Manufactured in
20725 NE 16th Ave Ste A26, N/A, Miami, FL, United States
Products
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2016Don't want to check this manually?
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