510(k) K853552

SENTRY FLEXIBLE TENS by Sentry Medical Products, Inc. — Product Code GXY

K853552 is an FDA 510(k) premarket notification submitted by Sentry Medical Products, Inc. for the device "SENTRY FLEXIBLE TENS". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Sentry Medical Products, Inc. has at least 10 other 510(k) clearances on record.