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510(k) Data Aggregation
K Number
K080506Device Name
MARTIN CHAIR, MODEL C4S1
Manufacturer
MARTIN MANUFACTURING CO., LLC
Date Cleared
2008-06-09
(105 days)
Product Code
IOR, LGX
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MARTIN MANUFACTURING CO., LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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,
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