SCIFIT STEP ONE - Page 30

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SCIFIT Scientic Solutions For Fitness SCIFIT Scientic Solutions For Fitness SCIFIT
SPECIFICATIONS


Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: 
Web: 
Manufacturer: SCIFIT Ltd (UK)
Product: Step One – Stepper
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in conformity
with the following standards and/or normative documents:
ISO 9001:2008
EN 957-1:2005
EN 957-8:1998
EN 60601-1-2:2007
EN 60601-1:2006
EN 62304:2006
Steve Wright
European Business Development Director
April 2, 2013
If your StepOne machine has CE on the label followed by
“0434”, it is a medical machine. The label will be located
at the front of the machine next to the serial number.







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
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








 


 


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0434

Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: 
Web: 
Manufacture: SCIFIT Ltd (UK)
Product: Step One – Recumbent Stepper
Class IIa device per rule 10 of Annex IX of 93/42/EEC.
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in conformity
with the essential requirements of the EC Council Directive 93/42 EEC Medical Device
Directive, as amended by 2007/47/EC and is in conformity with the following standards
and/or normative documents:
ISO 13485:2003
ISO 9001:2008
EN 957-1:2005
EN 957-8:2003
EN 60601-1-2:2007
EN 60601-1: 2006
EN 62304:2006
Steve Wright
UK Managing Director
17 January, 2013



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

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



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

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
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

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
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 
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