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510(k) Data Aggregation
K Number
K222818Device Name
Xpedition Powered Stair Chair (625700000000)
Manufacturer
Stryker Medical
Date Cleared
2023-01-24
(127 days)
Product Code
ILK
Regulation Number
890.5150Why did this record match?
Applicant Name (Manufacturer) :
Stryker Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xpedition transports a patient with a mobility-limiting medical condition or injury, who is physically able to maintain a seated position while restrained, up or down a set of stairs. Xpedition is intended for use in residential and commercial environments, including pre-hospital environments, emergency, and non-emergency applications. All operators, including healthcare professionals such as emergency medical service personnel and medical first responders, must be trained by a qualified trainer before product use.
Device Description
The Stryker Xpedition™ Powered Stair Chair is a seated patient transport device with handles and a powered belt and track system. The chair is designed to support and transport a maximum weight of 500 1b (227kg) up and down stairs. The chair is intended for patients who weigh 50 lb (23 kg) or more and can remain seated in the chair while secured by patient restraint straps. Handles at the head and foot ends allow operators to control the chair during powered or manual ascent or descent on stairs. Operators can push and maneuver the chair over various types of terrain expected in commercial and residential environments, as well as lift patients over obstacles. The chair has a removable patient containment system with attachment points for the chest and waist to secure a patient during transport. A fold-out footrest can be deployed for secure feet placement. A removable, rechargeable battery powers electrical functions including the motorized drive system for traversing stairs, speed selection, direction, ground lighting activation, battery capacity feedback, drive activation buttons, and LED visual feedback networks. User interfaces at the back of the chair and the top handle allow for drive system control. The chair has several mechanical activations including wheel locks to prevent unintended motion on ground, a latch to fold or unfold the chair, a track deployment mechanism to deploy the stair driving track system, and top and bottom handle length adjustment activations. Options include the footrest and head end flip-up carry handles.
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K Number
K180834Device Name
Altrix Precision Temperature Management System
Manufacturer
Stryker Medical
Date Cleared
2018-08-10
(133 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
Stryker Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Device Description
Altrix components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0 - 40.0° C and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
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K Number
K171149Device Name
Altrix Temperature Management Wraps
Manufacturer
Stryker Medical
Date Cleared
2017-07-18
(90 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
Stryker Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Device Description
The Altrix Temperature Management Wraps are the patient contact accessory for the Altrix Precision Temperature Management System. The Wraps are applied around the patient's thigh and torso. The Wraps are made from multiple layers of materials sealed together. A hose is used to connect the Wraps to the Altrix controller device.
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K Number
K152266Device Name
Altrix Precision Temperature Management System
Manufacturer
STRYKER MEDICAL
Date Cleared
2016-12-02
(479 days)
Product Code
DWJ, FLL
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
STRYKER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Device Description
The Altrix Precision Temperature Management System components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0° C (39.2° F) and 40.0° C (104.0° F) and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
The controller can supply water to an individual or multiple thermal transfer devices simultaneously with each of these circuits monitored separately. Three operating modes are available to facilitate patient care: Automatic, Manual and Monitor. The patient temperature probe is used with the controller to provide closed loop feedback for automatic patient temperature management and monitoring. The controller alarms activate visual and audible indications for when safety parameters are exceeded or it detects system function or performance irregularities. The Altrix system also includes the ability to provide a patient temperature output reference signal to be connected to a non-specific third party device/system.
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K Number
K113598Device Name
POWER-LOAD COT FASTENER SYSTEM
Manufacturer
STRYKER MEDICAL
Date Cleared
2011-12-20
(15 days)
Product Code
FPO, CLA
Regulation Number
880.6910Why did this record match?
Applicant Name (Manufacturer) :
STRYKER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power-LOAD™ cot fastening system (model 6390) is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lbs, which includes the weight of the ambulance cot, patient, and equipment attached to the cot (i.e. oxygen bottles, monitors, and/or pumps). The intended users of the device will be trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. The expected service life of the product is 7 years.
Device Description
The Power-LOAD system secures an ambulance cot within an emergency transport vehicle/ambulance. Power-LOAD includes a trolley that attaches to the cot during the loading and unloading process, a transfer assembly that facilitates linear motion of the trolley and an anchor assembly that attaches to a floor plate mounted to the vehicle floor. When a Power-LOAD-compatible cot is securely attached to the trolley, a batterypowered hydraulic system assists the operators in lifting, lowering and loading and unloading a cot. When the cot is secured in the transport position, Power-LOAD can interface with and inductively charge compatible model 6506 Power-PRO™ XT and 6516 Power-PROTM IT ambulance cots. In the event of power loss, the system remains functional for securing the cot within the vehicle. In this case, loading and unloading of the cot would be achieved manually, as is standard practice today. There will be three cots compatible with Power-LOAD, Power-PRO XT, Power-PRO IT and Performance-PRO XT.
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