Device Recall TempPad Cold Therapy Pad .

  • 모델명 / 제조번호(시리얼번호)
    Part #: 50625, Catalog number: 510-US, Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; Part #: 50633, Catalog #: 510-USS, Lot #: 08537, 08675, 08953; Part #: 50627, Catalog #: 814-US, Lot #: 08610; Part # 50634, Catalog # 814-USS, Lot #: 08611, 08919, 09466; Part #: 50628, Catalog #: 1112-US, Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; Part #:50635, Catalog #: 1112-USS, Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; Part #: 50629, Catalog #: 1215-US, Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218 & Part #: 50137, and Catalog #: CT-99, Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.
  • 제품 설명
    TempPad¿ Cold Therapy Pad. || The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
  • Source
    USFDA