MW8 & MotionWare User Guide: Issue 1.2.1
Page 2
MotionWatch Regulatory Information
Medical Device Directive
(European Union)
The MotionWatch is a Class I Medical Device conforming to the
essential safety & health requirements and provisions of EC
Council
Directives 93/42/EEC, Annex VII. An EC declaration of Conformity will
be provided upon request.
US FDA status
The MotionWatch is FDA cleared for prescription use only with FDA
510(k) number K132764.
Health Canada
The MotionWatch is licensed for clinical use in Canada with HC
license number 94219.
Australian TGA
The MotionWatch has been cleared by the Australian TGA and is
listed on the ARTG with ref no: 219452
Australian Sponsor
: Please note that the sponsor should be
contacted
ONLY
to report adverse events
– all sales and support
issues must be directed to CamNtech in the UK.
Emergo Australia
Level 20
Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
Manufacturer:
CamNtech Ltd
Upper Pendrill Court
Papworth Everard
Cambridgeshire
CB23 3UY, UK
Tel: 01480 831223
Fax: 01480 831733
Email:
Web:
www.camntech.co.uk
