ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN

ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN is an FDA 510(k)-cleared medical device (K871125) manufactured by Biomedical Life Systems, 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 1, 1987. Regulation: 8.