Journal of Korean Society of Health-System Pharmacists

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Table. 3.

Table. 3.

Digital therapeutics approved as medical devices

제품명 reSET-O PROPELLER SYSTEM-MODEL 2
개발회사 Pear Therapeutics, Inc. Reciprocal Labs Corporation (Propeller Health)
신청일 12/01/2017 03/12/2014
허가일 12/10/2018 05/02/2014
기능 Cognitive behavioral therapy to treat substance use disorder. Intended for single-patient use to assist physicians and patients in recording and monitoring the actuation of prescribed MDI usage.
물리적 형태 A software-based mobile app downloaded onto a smartphone. Software that, like the Propeller Mobile Application, is intended to allow users to review the collected information
허가경로 510(k) 510(k)
위험등급 2 2
De Novo(결정일) FDA concludes that this device should be classified into Class II. (09/14/2017) 해당 없음

자료: 미 FDA 허가 정보

J. Kor. Soc. Health-syst. Pharm. 2021;38:281-90
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