RotoProne Therapy System

  • Modèle / numéro de série
    Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; and RRJK00002
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
  • Description du dispositif
    RotoProne Therapy System, Model 209500, Device List Number E232632 || Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    KCI USA, Inc., 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA

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  • Modèle / numéro de série
    SERIAL NUMBERS:  RRFK00041, RRFK00083, RRFK00232, RRFK00233, RRFK00276, RRFK00229, RRFK00215, RRFK00221, RRFK00243, RRFK00121, RRFK00263, RRFK00094, RRFK00150, RRFK00274, RRFK00103, RRFK00198, RRFK00256, RRFK00111, RRFK00290, RRFK00091, RRFK00044, RRFK00087, RRFK00241, RRFK00047, RRFK00186, RRFK00059, RRFK00170, RRFK00246, RRFK00064, RRFK00071, RRFK00289, RRFK00056, RRFK00078, RRFK00178, RRFK00051, RRFK00248, RRFK00155, RRFK00202, RRFK00247, RRFK00128, RRFK00228, RRFK00269, RRFK00126, RRFK00277, RRFK00207, RRFK00253, RRFK00067, RRFK00280, RRFK00108, RRFK00174, RRFK00161, RRFK00105, RRFK00125, RRFK00240, RRFK00052, RRFK00102, RRFK00147, RRFK00153, RRFK00082, RRFK00062, RRFK00225, RRFK00265, RRFK00070, RRFK00104, RRFK00123, RRFK00172, RRFK00085, RRFK00069, RRFK00190, RRFK00252, RRFK00287, RRFK00050, RRFK00119, RRFK00210, RRFK00239, RRFK00169, RRFK00191, RRFK00149, RRFK00168, RRFK00162, RRFK00226, RRFK00068, RRFK00284, RRFK00107, RRFK00227, RRFK00049, RRFK00166, RRFK00194, RRFK00196, RRFK00216, RRFK00148, RRFK00230, RRFK00266, RRFK00143, RRFK00097, RRFK00199, RRFK00223, RRFK00188, RRFK00101, RRFK00164, RRFK00037, RRFK00167, RRFK00192, RRFK00055, RRFK00086, RRFK00173, RRFK00177, RRFK00222, RRFK00238, RRFK00189, RRFK00038, RRFK00165, RRFK00099, RRFK00160, RRFK00141, RRFK00201, RRFK00043, RRFK00080, RRFK00112, RRFK00209, RRFK00124, RRFK00146, RRFK00042, RRFK00066, RRFK00184, RRFK00106, RRFK00224, RRFK00275, RRFK00180, RRFK00115, RRFK00251, RRFK00278, RRFK00237, RRFK00283, RRFK00219, RRFK00254, RRFK00179, RRFK00211, RRFK00127, RRFK00117, RRFK00157, RRFK00120, RRFK00073, RRFK00193, RRFK00195, RRFK00218, RRFK00096, RRFK00095, RRFK00204, RRFK00053, RRFK00282, RRFK00113, RRFK00200, RRFK00264, RRFK00118, RRFK00109, RRFK00122, RRFK00261, RRFK00244, RRFK00187, RRFK00039, RRFK00152, RRFK00181, RRFK00206, RRFK00231, RRFK00046, RRFK00093, RRFK00159, RRFK00088, RRFK00154, RRFK00076, RRFK00145, RRFK00175, RRFK00270, RRFK00065, RRFK00089, RRFK00054, RRFK00213, RRFK00040, RRFK00057, RRFK00156, RRFK00144, RRFK00249, RRFK00258, RRFK00045, RRFK00092, RRFK00176, RRFK00142, RRFK00036, RRFK00242, RRFK00151, RRFK00183, RRFK00060, RRFK00257, RRFK00061, RRFK00074, RRFK00217, RRFK00273, RRFK00171, RRFK00250, RRFK00158, RRFK00220, RRFK00163, RRFK00208, RRFK00279, RRFK00205, RRFK00098, RRFK00288, RRFK00063, RRFK00110, RRFK00072, RRFK00235, RRFK00267, RRFK00077, RRFK00079, RRFK00081, RRFK00182, RRFK00090, RRFK00197, RRFK00214, RRFK00084, RRFK00100, RRFK00245, RRFK00075, RRFK00114, RRFK00260
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
  • Description du dispositif
    Rotoprone Therapy System. || The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
  • Manufacturer
  • Modèle / numéro de série
    Serial Numbers: RRFK00036 - RRFK00128.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Devices distributed nationwide.
  • Description du dispositif
    RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
  • Manufacturer
  • Modèle / numéro de série
    Arjo RotoProne Therapy System
  • Description du dispositif
    Beds, Electric, Rotation
  • Manufacturer
  • Modèle / numéro de série
    Model No. : 209500
  • Description du dispositif
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.
  • Manufacturer
  • Modèle / numéro de série
    Model #209500
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide and Middle East
  • Description du dispositif
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. || Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
  • Manufacturer