https://join.gov.tw/idea/detail/b3c4a81d-356a-41de-835a-d70e64f37f4f#endorses
請幫忙宣傳，支持
https://www.mobile01.com/topicdetail.php?f=470&t=5924542
反正文件不是我寫的，僅供參考了。
至於有沒有參考價值，看人了。
AW馬上變成醫療器材，怎麼可能呢？
FDA說：
Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies.
來源FDA給apple的文件
https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf
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