510(k) K091757

OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 by Well-Life Healthcare Limited — Product Code NUH

K091757 is an FDA 510(k) premarket notification submitted by Well-Life Healthcare Limited for the device "OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407". The FDA issued a decision of Substantially Equivalent on February 5, 2010. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Well-Life Healthcare Limited has at least 10 other 510(k) clearances on record.