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510(k) Data Aggregation

    K Number
    K112944
    Device Name
    FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
    Manufacturer
    FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.
    Date Cleared
    2011-12-30

    (87 days)

    Product Code
    INO, FKS
    Regulation Number
    890.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Treatment Chair, T688 Series is intended for use in medical procedures such The Medical Preatinent Chalysis to, and collecting blood from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chair is also intended for use in day surgery and nursing homes. T688 chair is I readined so that the occupant is accommodated in a seated position with the hips moved designed so that the occupant is against the back rest and the legs outstretched and supported by the seat and leg rests. T688 chair is also used to position patients for easy access by healthcare professionals. The I voo enair is designed so that the occupant is accommodated in a seated position with the hips enair is decired or that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. This chair is intended to be used by patients with a weight not exceeding: - 200kg (T688 series) .
    Device Description
    T688 series chair is used to aid medical procedures such as renal dialysis, blood collection and chemotherapy and is called as Medical Treatment Chair. T688 series is electric-powered treatment chair with the following features: - Power-operated seat and leg rest and back rest reclines, with options offering one-. touch memorized positions - Swing Out Side/Arms . - Adjustable head/neck rest . - Adjustable height . - CPR support posts, gas spring assisted back rest and accessories. . - . Fold-down trays - Four individually locking castors . - Heavy duty washable vinyl . - Removable upholstery . - The chair will recline to Trendelenburg position . - Suitable for side transfer of patients . - No timber included in the frame . - Battery back-up-24V rechargeable . - 2 Actuators & 1 Column . - Compact Design . - Lighter weight . - Reduced components ● The device is classified as: - Class II (FKS, INO) electric-powered version. . Specific ancillary devices and accessories are not listed here due to the wide variety of procedures in which the chair is used.
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    K Number
    K091727
    Device Name
    MEDICAL TREATMENT CHAIR, T400, T500,T600
    Manufacturer
    FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.
    Date Cleared
    2009-07-06

    (25 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking bloods from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use in day surgery and nursing homes. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. All models are intended to be used by patients with a weight not exceeding: - 130kg (T100 and T200 series) - 130kg (T300 and T400 series) - 200kg (T500, T550, T600 and T650 series) - 300kg (T500B, T600B)
    Device Description
    The range of chairs, used to aid medical procedures such as renal dialysis, blood collection and chemotherapy, are called Medical Treatment Chairs and are made up of models T-100, 200, 300, 400, 550, 500B, 550, 600, 600B, 650: The manually-operated range of treatment chairs (T100, 200, 300) typically have the following features: - Manually-operated recliner - Adjustable head/neck rest - Upholstered arms - Four locking braked castors - Vinyl-covered - The T100, T200 and T300 models offer optional CPR support posts, gas spring assisted back rest and accessories, whilst other models come standard with these features - Fold-down trays - Fold-out arms The electric-powered range of treatment chairs (T400 through to T600 series) offer the above features in addition to: - power-operated seat and leg rest and back rest reclines, with some models offering one-touch memorized positions - battery back-up 24V rechargeable - height-adjustable swing-out arm rests (except the T400) The electric-powered chairs, depending on the model, may have different numbers of actuators, i.e: - T400 2 actuators - T500 2 actuators - T500B 2 actuators, reinforced frame - T550 3 actuators - T600 3 actuators - T600B 3 actuators, 2 motors, reinforced frame, extra lift levers - T650 3 actuators The device is classified as: - Class I (FMR) - Class II (FKS, INO) electric-powered version. Specific ancillary devices and accessories are not listed here due to the wide variety of procedures in which the chair is used.
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