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並前往https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-D/section-878.3900

21 CFR 878.3900 -- Inflatable extremity splint. - eCFR

An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity. (b) Classification. Class I (general controls).

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