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The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical's AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

The Model 5212 iBed™ Wireless with iBed™ Mobile consists of iBed™ Wireless (WiFi module) and the iBed™ Mobile software application that is intended to be used with Stryker Medical's ACpowered adjustable hospital beds within a healthcare delivery organization. The iBed™ Wireless with iBed™ Mobile device accessory is an updated software platform that provides bi-directional data transmission between Stryker Medical's AC-powered adjustable hospital beds equipped with iBed™ Wireless, the healthcare delivery organization's server (owned and maintained by the healthcare delivery organization), and a healthcare professional's handheld electronic device. It is a convenience tool facilitating bi-directional data transmission of bed status data and parameters allowing healthcare professionals the ability to set, adjust, and monitor bed status from a remote location within the healthcare delivery organization facility.

The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill- Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill- Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. The Hill-Rom Wireless Connectivity Module is integrated into existing bed platforms via a USB connection to the bed's electrical system and provides connectivity to a remote server application. The Hill-Rom Wireless Connectivity Module is used to assist staff to monitor hospital bed status and to assist the healthcare provider in providing patient care. The optional feature is mounted onto Hill-Rom hospital beds to wirelessly transmit bed information such as: bed exit status, bed side rail status, bed brake status, head of bed angle, and patient weight from bed scale. The Hill-Rom Wireless Connectivity Module is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device which communicates with a remote server in the hospital. The bed status data may be displayed at user-defined locations, such as nursing stations. It may also be shared with EMR (Electronic Medical Record) Systems through integration with 3rd party systems.

The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.

The intended use for the iBed™ Wireless (with iBed™ Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBed™ Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed™ Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBed™ Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBed™ Wireless with iBed™ Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed™ Wireless with iBed™ Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The iBed™ Awareness is used to monitor hospital bed status and to assist the Healthcare Provider in providing patient care. The system is integrated into Stryker hospital bed to monitor bed information such as: iBed™ Awareness status, bed exit status, siderail status, bed brake status, fowler angle, and weight on bed, for example. The Healthcare Professional can set the alerting function (audible and lights) to activate if bed status has changed. The iBed™ Wireless device is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device to the hospital server. The data can be captured by hospital data collection systems (developed and provided by Third Parties; not part of this submission). Through the use of the third party software, the data may be displayed at user-defined locations, such as nursing stations.

The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table. The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.

The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons. The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use. The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,

The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility. Examples of usage include: - a single operator may move empty beds to staging or storage areas within the healthcare facility. - a single operator may move patient-laden beds from one location to another within the healthcare facility.

The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility. Only the caregiver, not the patient, can control this powered assistive device. This device is not permanently attached to or made a part of the stretcher or bed. The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.

- (1) May Provide Temporary Relief of Low Back Pain; - May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatirue (2) or: Overexertion; - May Provide Temporary Relief of Edema or Swelling of the Legs; (3) - May Provide Temporary Relief of Poor Local Blood Circulation of the Legs;" (4) - May Provide Temporary Relief from Symptoms of Hiatus Hernia; (5) - May Provide Temporary Relief from the Symptoms of Gastric Reflux; (6) - May Provide Temporary Relief of Nighttime Heattburn; (7) - The Optional Heating Accessory Provides Temporary Relief from Mild Arthritis (8) and Joint Pain, as well as Muscle Pain Associated with Stress and Tension; and - Sleeping in an Upright Position May Reduce or Fase Light and Occasional (ව) Snoring. **

Craftmatic® Adjustable Beds are electrically powered adjustable beds for home use that adjust into 1001 various positions (e.g., raising the torso, the legs, or both to various heights). The beds have three primary components: (1) a steel bed frame with lift motors, (2) a mattress, and (3) a pendant control. Powered heating pads, which cover the entire mattress, and physical therapy pulsators (built-in massage units) are optional.

The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient

The product consists of mechanical, electromechanical, hydraulic, and electronic components. These may be selected by the caregiver or institution to customize the bed to specific patient population needs.