510(k) K203847

Reprocessed Tri Pulse Compression Garment by Renu Medical, Inc. — Product Code JOW

K203847 is an FDA 510(k) premarket notification submitted by Renu Medical, Inc. for the device "Reprocessed Tri Pulse Compression Garment". The FDA issued a decision of Substantially Equivalent on May 7, 2021. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Renu Medical, Inc. has at least 8 other 510(k) clearances on record.