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510(k) Data Aggregation
K Number
K072598Device Name
IRSG I-MOVER FOR BEDS
Manufacturer
INTERNATIONAL RETAIL SERVICES GROUP, LLC
Date Cleared
2008-04-14
(213 days)
Product Code
FPO
Regulation Number
880.6910Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL RETAIL SERVICES GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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