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  • Declaration of Conformity MDR
  • FDA- U.S. Food & Drug Administration

TOTIM Patient Cushion Immobilization System FDA 510(k) Cleared Class II - K 190894

  • TOTIM Cleared China - Approval Date: 9 Dec, 2020 Reg No: 国械备20200697
  • Japan Minister of Health, Labour and Welfare Medical Device
  • Australian Government Department of Health Therapeutic Goods Administration