TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM

TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K911101) manufactured by Zofcom, Inc.. 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 April 24, 1991. Regulation: 8.