DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE is an FDA 510(k)-cleared medical device (K101889) manufactured by Pivotal Health Solutions. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2010. Regulation: 8.