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510(k) Data Aggregation
K Number
K101723Device Name
COMPACT WHEELCHAIR PLATFORM
Manufacturer
DESIGN SPECIFIC FLETCHER
Date Cleared
2010-12-23
(188 days)
Product Code
INO
Regulation Number
890.3110Why did this record match?
Applicant Name (Manufacturer) :
DESIGN SPECIFIC FLETCHER
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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