Quality, Regulatory & Government


  • ISO 9001 registered since 1998
  • ISO 9001:2015 registration, certificate number C0098586-IS5 with NSF International Strategic Registrations
  • A copy of our certification can be found here


  • FDA registered compression hosiery manufacturer since 1993.
  • FDA Registration number 1057079
  • Class 1 (stocking, medical support for general medical purposes) listing number D132797, premarket submission exempt, product code FQL
  • Class 2 (stocking, medical support to prevent pooling of blood in legs) listing number D132795, premarket submission number K925643, product code DWL

Production Standards

  • Producing to British Standard for compression and British Drug Tariff 40 since 1996
  • Producing to French ASQUAL standard for compression since 2011
  • Producing to German RAL-GZ 387 standard for compression since 2016
  • Only U.S. member of German Quality Mark Association for Compression (one of twenty-two companies globally). A copy of our certification can be found here
  • Select products OEKO-TEX standard 100 certified


  • Products registration for European CE mark
  • Customers EU Medical Device Regulation (MDR) compliance
  • Unique Device Identifier (UDI) compliance
  • Registration as compression hosiery manufacturer in Russia, South Korea, Japan, Australia, Canada, Guatemala, Peru, and China


  • Restriction of Hazardous Substances (RoHS) compliant
  • REACH Substances of Very High Concern (SVHC) compliant
  • Zero Discharge of Hazardous Chemical Program (ZDHC) compliant
  • California Proposition 65 compliant

U.S. Government

  • Primary NAICS code 339113 (alternate is 315110)
  • System for Award Management (SAM) registered
  • DUNS: 362250904
  • CAGE Code: oXN72
  • Manufacturing site is in a HUB Zone
  • Berry Amendment compliance is an option