SCIFIT • Scientific Solutions for Fitness • SCIFIT • Scientific Solutions for Fitness • SCIFIT
12
CerTIFICaTIonS
If your ISo1000r/7000r 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.
DECLARATION OF CONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
Web:
www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product:
ISO1000R Recumbent Bike
Class A (high accuracy class) per EN957-1:2013
Class S (commercial use class) per EN957-1:2013
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 957-1:2013
EN 957-5:2009
EN 60601-1-2:2007
EN 60601-1:2006
EN 62304:2006
Steve Wright
European Business Development Director
January 4, 2015
DECLARATION OF CONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
Web:
www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product:
ISO7000R Recumbent Bike with reversible cranks
Class A (high accuracy class) per EN957-1:2013
Class S (commercial use class) per EN957-1:2013
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 957-1:2013
EN 957-5:2009
EN 60601-1-2:2007
EN 60601-1:2006
EN 62304:2006
Steve Wright
European Business Development Director
January 4, 2013
0434
DECLARATION OF CONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
Web:
http://www.scifit.uk.com/
Product:
ISO1000R Recumbent Bike
Class IIa device per rule 10 of Annex IX of 93/42/EEC.
Class A (high accuracy class) per EN957-1:2013
Class S (commercial use class) per EN957-1:2013
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, as amended by 2007/47/EC and is in conformity with the
following standards and/or normative documents:
ISO 13485:2012
ISO 9001:2008
EN 957-1:2013
EN 957-5:2009
EN 60601-1-2:2007
EN 60601-1: 2005
EN 62304:2006
Steve Wright
UK Managing Director
October 14, 2014
0434
DECLARATION OF CONFORMITY
Address:
SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email:
Web:
http://www.scifit.uk.com/
Product:
ISO7000R Bidirectional Recumbent Bike
Class IIa device per rule 10 of Annex IX of 93/42/EEC.
Class A (high accuracy class) per EN957-1:2013
Class S (commercial use class) per EN957-1:2013
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, as amended by 2007/47/EC and is in conformity with the
following standards and/or normative documents:
ISO 13485:2012
ISO 9001:2008
EN 957-1:2013
EN 957-5:2009
EN 60601-1-2:2007
EN 60601-1: 2005
EN 62304:2006
Steve Wright
UK Managing Director
October 14, 2014
SCIFIT • Prescribed for Progress • SCIFIT • Prescribed for Progress • SCIFIT • Prescribed for Progress
