
Eswallow USA
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ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT is an FDA 510(k)-cleared medical device (K092202) manufactured by Eswallow USA. 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 February 9, 2011. Regulation: 8.