510(k) K911911

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM by Medical Design & Manufacturing Corp. — Product Code HCC

K911911 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 1992. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.