BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD

BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD is an FDA 510(k)-cleared medical device (K983520) manufactured by Sunrise Medical, 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 November 5, 1998. Regulation: 8.