Regulatory Compliance Information

Quality Management Systems

• US FDA Good Manufacturing Practice (GMP)

  We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations and are registered with them and the State of California to manufacture medical devices.

• Europe & International

  We are not ISO certified as all of our products are classified as Class I.

Product Certifications and Approvals

• United States

  All our products are Class I in the US, so we are exempt from submitting a 510(k); below are links to our device classification based on its intended use from the FDA website:

  Cervical Truncal Orthosis:

  Aspen® Collar »
  Vista® Collar »

  Thoracic Truncal Orthosis:

  TLSO »

  Lumbar Truncal Orthosis:

  LSO »
  Contour™ LSO »
  QuikDraw™ »

  Global Regulatory Representative

  EUROPE - Authorized Representative
  Emergo Europe, The Hague
  NETHERLANDS
  phone: +31.70.345.8570
  www.EmergoGroup.com »

• Europe - CE Marking

  All our products are Class I in Europe so we self certify the CE mark meaning we have no formal certificates from our Notified Body.

  Europe - Declarations of Conformity

  Aspen® Collar PDF »
  Contour™ LSO/ TLSO PDF »
  Vista® Collar PDF »
  Summit™ 631 PDF »
  LSO PDF »
  TLSO PDF »
  CTO PDF »
  QuikDraw™ RAP PDF »
  Sierra™ Collar PDF »

  CHINA - SFDA Approved Devices

  Aspen & Vista Collar Certificate »
  LSO & TLSO »
  QuikDraw RAP & Contour LSO Certificate »