510(k) K221384

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 by Hivox Biotek, Inc. — Product Code NUH

K221384 is an FDA 510(k) premarket notification submitted by Hivox Biotek, Inc. for the device "Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2". The FDA issued a decision of Substantially Equivalent on June 11, 2022. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Hivox Biotek, Inc. has at least 10 other 510(k) clearances on record.