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510(k) Data Aggregation

    K Number
    K131909
    Device Name
    DALTON LIFT CHAIR
    Manufacturer
    DALTON INSTRUMENT CORP.
    Date Cleared
    2014-02-24

    (243 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Device Description
    The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.
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    K Number
    K123834
    Device Name
    EASYSTAND BANTAM MEDIUM
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Date Cleared
    2013-08-13

    (243 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altimate Medical EasyStand Bantam Medium is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200lbs.
    Device Description
    The EasyStand Bantam Medium is a standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is a sitto-stand stander with the option of supine positioning. The optional Shadow Tray supports the user from sitting to standing and can be used as a desk/workstation in the seated and /or standing position. The device offers two options to raise the seat, the standard nanual hydraulic lift or the optional Pow'r Up lift. The Bantam Medium accommodates most individuals within the height range of 48"-66" and up to 200 lbs.
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    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?
    Product Code :

    INO

    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
    K101723
    Device Name
    COMPACT WHEELCHAIR PLATFORM
    Manufacturer
    DESIGN SPECIFIC FLETCHER
    Date Cleared
    2010-12-23

    (188 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The clinical treatment of persons in wheelchairs presents a significant issue for the clinician. Treatments related to a patient's head often require them to be reclined. The platform allows for reclining the wheelchair giving full support to both patient and clinician. The hazards associated with transfers to other couches or chairs are eliminated. Typical treatments would include: Dental, Maxiliofacial work, Ear, Nose and Throat procedures, Eye treatments and surgery, Podiatry.
    Device Description
    The Compact Wheelchair Platform (CWP) is designed to assist in the clinical treatment of wheelchair users by providing a convenient wheelchair accessible platform that can be tilted so that the head is placed in the optimum position of comfort for both staff and patient. It is a direct development of the Mobile Wheelchair Platform (K073565). The complete redesign more than halved the storage area and up-graded the load from a SWL of 594lb to 825lbs. The angle of tilt has been altered to 60deg to provide a recovery position. The Wheelchair platform is supported on two side frames with a high pivot point. The hydraulic cylinders are below the pivot and retract to tilt the platform. This gives a very compact form and with a hinged platform base the whole unit is no more than 24" wide. It can be easily moved through doors for sharing with other opertories. The whole construction is aerospace high strength aluminium alloys or stainless steel giving a high strength weight ratio. The unit is powered at 24v. The main source of power is from a pair of 12v lead acid batteries that can be easily replaced and last for at least 40 full cycles before needing to be recharged. A dc supply is provided to operate the machine from the mains supply if needed. The control is via a PCB with a PIC logic controller. All switching takes place at 5v and makes the controls light and reliable. The logic capability allows continuous monitoring of safety switching and the integration of good safety procedures. A radio handset is normally used to control the platform eliminating any trailing wires. Safety is a major concern and entrapment is eliminated by using sensitive, fail-safe, strip switches at all sensitive points on the mechanism. The radio handset and fixed switches on the machine are supplied to operate the device, duplicating the control function. All control and drive elements are housed safely under a cover. The machine has clean lines and is easily cleaned with wipe over surfaces.
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    K Number
    K091578
    Device Name
    LIFT CHAIR, MODEL T3
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Date Cleared
    2009-12-02

    (183 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Device Description
    The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.
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    K Number
    K091242
    Device Name
    BANTAM
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Date Cleared
    2009-07-06

    (69 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altimate Medical EasyStand Bantam is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.
    Device Description
    The EasyStand Bantam is a standing frame for indov use that allows users with various degrees of pirysical disability to ob supported in a suitioning, weight-bearing position. The optional Shadow Tray device is a sit-io stands standing and can be used as a desk/workstation in the seated and/or standing position. The device comes in two il (accommodating individuals ranging in height from 28" – 40" (71cm – 102 cm) and so books (23kg) and small (accommodating individuals ranging in height from 20" – 10 – 10 – 10 – 137 cm - 137 cm) and up to 100lbs (23kg).
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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?
    Product Code :

    INO

    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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    K Number
    K073565
    Device Name
    STANDARD WHEELCHAIR PLATFORM
    Manufacturer
    DESIGN SPECIFIC LTD
    Date Cleared
    2009-02-06

    (415 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks. The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.
    Device Description
    The device accommodates wheelchairs in a secure way, to enable them to be tilted backwards. Patient support is by an adjustable backrest with head support using an adjustable head cushion. The primary use is with patients who cannot be easily transferred from their chairs for such procedures as dentistry, Podiatry, Ear, nose and throat, maxio-facial work. Basic Platform shape: Steel fabrication. Drive mechanism: Electrical Linear Drive. Power source: Battery 24v and Power supply delivering 24v. Backrest support: Pivots in and out adjustable by worm and wheel. Headrest: Adjustable using a slotted arm with an adjustable headrest cushion for neck and head support. Motions command input: Tilt only Fixed switches and radio remote control. Foot crush protection: Pressure sensitive mat and guarding. Max. angle of tilt: 45deg. Rated capacity: 594lb (BSEN1570:1999). Proposed uses: Dental and medical applications. Static or mobile: Mobile on air cushion pads or ball castors.
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    K Number
    K081053
    Device Name
    PIVOT ASSIST
    Manufacturer
    PIVOT ASSIST, LLC
    Date Cleared
    2008-10-09

    (178 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K080533
    Device Name
    WINCO MODEL POWER SERIES LIFT CHAIR
    Manufacturer
    WINCO, INC.
    Date Cleared
    2008-08-11

    (167 days)

    Product Code
    INO
    Regulation Number
    890.3110
    Why did this record match?
    Product Code :

    INO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist persons who have difficulty rising from a seated position to a standing position.
    Device Description
    The Winco Models Power Series Lift Chairs are electro mechanical devices designed for use in the home or a health care setting. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position, when seated. The Winco Series Lift Chairs consist of two models; the model 696 lift chair and the model 905 lift chair. The model 696 chair is the standard version and is designed to accommodate most users. It is smaller and lighter than the model 905 chair, and has a maximum weight capacity of 300 lbs. The model 905 lift chair is designed for bariatric users. It is wider than the standard 696 chair and has a maximum weight capacity of 600 lbs.
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