
Suzhou Medical Appliance Factory
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HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL is an FDA 510(k)-cleared medical device (K063568) manufactured by Suzhou Medical Appliance Factory. 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 March 21, 2007. Regulation: 8.