U.S. FDA Medical Device Examination & Treatment Chair Requirements
FDA Medical Device Definition: A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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