Device Recall Rheo Knee

  • 모델명 / 제조번호(시리얼번호)
    Rheo 2 Item Number: RKN120007  Serial #s affected:  323056 321498
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US distribution in TN and country of: Austria.
  • 제품 설명
    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • 제조사 모회사 (2017)
  • Source
    USFDA