BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 is an FDA 510(k)-cleared medical device (K052625) manufactured by Bionicare Medical Technologies, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2005. Regulation: 8.