SCIFIT • Scientic Solutions for Fitness • SCIFIT • Scientic Solutions for Fitness • SCIFIT
27
CERTIFICATIONS
0434
DECLARATION OF CONFORMITY
Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: info@scifit.uk.com
Web: www.scifit.uk.com
Manufacture: SCIFIT Ltd (UK)
Product: ISO1000 Upright Bike
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 tha
t 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 957-5:2009
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
UK Managing Director
17 August, 2012
0434
DECLARATION OF CONFORMITY
Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: info@scifit.uk.com
Web: www.scifit.uk.com
Manufacture: SCIFIT Ltd (UK)
Product: ISO7000 Bidirectional Upright Bike
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., h
ereby 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 957-5:2009
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
UK Managing Director
17 August, 2012
If your ISO1000/7000 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: info@scifit.uk.com
Web: www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product: ISO1000 Upright Bike
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 follo
wing standards and/or normative documents:
ISO 9001:2008
EN 957-1:2005
EN 957-5:2009
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
European Business Development Director
January 4, 2012
DECLARATION OF CONFORMITY
Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: info@scifit.uk.com
Web: www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product: ISO7000 Upright Bike with reversible cranks
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
co
nformity with the following standards and/or normative documents:
ISO 9001:2008
EN 957-1:2005
EN 957-5:2009
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
European Business Development Director
January 4, 2012
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