510(k) K960036

FIRARD II/ TDP LAMP by Helio Medical Supplies, Inc. — Product Code ILY

K960036 is an FDA 510(k) premarket notification submitted by Helio Medical Supplies, Inc. for the device "FIRARD II/ TDP LAMP". The FDA issued a decision of Substantially Equivalent on June 6, 1996. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Helio Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.