Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Fukuda Denshi USA, Inc.
Free shipping on orders over $99 · 30-day returns
FUKUDA DENSHI is an FDA 510(k)-cleared medical device (K103134) manufactured by Fukuda Denshi USA, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2011. Regulation: 8.