REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600

REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 is an FDA 510(k)-cleared medical device (K013328) manufactured by Remington Products Company, LLC. 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 December 2, 2001. Regulation: 8.