
Bionicare Medical Technologies, Inc.
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MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 is an FDA 510(k)-cleared medical device (K030332) 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 June 5, 2003. Regulation: 8.