Events

IF Electrostatic Therapy Device 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 연번
    2018-259
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525482-fda-advisory-no-2018-259
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2018-259 public health warning against the unapproved and misleading advertisements and promotion of if electrostatic therapy device the food and drug administration (fda) warns the public against the unapproved, false and misleading advertisements and promotion of if electrostatic therapy device monitored from flyer collected from ok dok  at 43 annapolis tower greenhills  san juan. the public is hereby warned that the aforementioned claims were not duly approved by the fda. any health device products should not bear any misleading, deceptive and false claims in their labels and/or any promotional materials that will provide erroneous impression on product’s character and identity. hence, false and misleading advertisement of health devices may harm and cause potential risk to the consumers. on the other hand, the false, deceptive and misleading advertisement of these health devices, constitutes violation of title iii, chapter i of the republic act no. 7394, otherwise known as the consumer act of the philippines of 1992.  for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-259.Pdf.

Device

IF Electrostatic Therapy Device
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP