Search Results
Found 8 results
510(k) Data Aggregation
K Number
K152056Device Name
Winco Model S550 Stretchair
Manufacturer
WINCO MANUFACTURING LLC
Date Cleared
2016-04-11
(262 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.
Device Description
The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its' intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position.
The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.
Ask a Question
K Number
K140095Device Name
PRIME ZOOM STRETCHER
Manufacturer
STRYKER CORPORATION
Date Cleared
2014-05-20
(126 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.
The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
Device Description
The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.
Ask a Question
K Number
K112502Device Name
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
Manufacturer
HILL-ROM CO.
Date Cleared
2011-09-19
(20 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
Device Description
The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.
Ask a Question
K Number
K110671Device Name
WINCO STRETCHAIR
Manufacturer
WINCO MFG., LLC
Date Cleared
2011-04-22
(44 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.
Device Description
The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.
The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.
Ask a Question
K Number
K102236Device Name
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
Manufacturer
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
Date Cleared
2010-11-18
(101 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
Device Description
The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
Ask a Question
K Number
K091043Device Name
POWER DRIVE CHAIR, MODEL: TMM6
Manufacturer
TRANSMOTION MEDICAL INC.
Date Cleared
2009-05-11
(28 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TransMotion Medical Model TMM6 Power Drive Chair is intended to provide a method of transporting patients within health care facilities.
The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (≤ 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.
Device Description
The TransMotion Medical, Inc. TMM6 Power Drive Chair (TMM6) is a battery powered device designed for use in short term (≤ 23 hours) patient care facilities. Its intended function and use is to transport patients within the confines of the facility, where patient function and use is to transport patient used to support the patient during examinations, care is boing administer clinical activity which may take place in the facility.
The TMM6 is unique in that it can support and transport patients in either a supine The TMMO is unique in that it can supportures 1 and 2 below). This enhances patient (laying) poregivers and also provides for greater patient comfort.
Ask a Question
K Number
K051861Device Name
THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777
Manufacturer
SAVION INDUSTRIES, LTD.
Date Cleared
2005-09-28
(83 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
the device is a motorized device intended for medical purposes to assist in transfer of patient to and from beds, chairs, treatment facilities. wheelchairs or transport vehicles.
Device Description
the Savion Industries "Medi-Cruiser" model MS777 Stretcher is a motorized patient transport stretcher / trolley. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
Ask a Question
K Number
K041924Device Name
HAUSTED POWERTRAN SERIES STRETCHER
Manufacturer
STERIS Corporation
Date Cleared
2004-09-09
(55 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Search-Everything :
Matched: '890.3690'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified powered patient transports as a Class II device.
Device Description
The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified the device as a Class II device. The FDA has classified powered patient transports as a Class II device.
The Hausted® POWERTRAN™ Series Stretcher is designed to assure compliance with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). The device will also carry the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings. Electrical testing will be certified by the accredited testing facility shown at the end of this certification. Software testing is being certified by STERIS as the manufacturer.
Ask a Question
Page 1 of 1