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

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Patent SM-P-201700411 
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