510(k) K871421

MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT by Futuremed Div. of Future Impex Corp. — Product Code IPF

K871421 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.