21
EC Declaration of Conformity
OrthoMotion Inc. declares that the following Continuous Passive Motion (CPM)
medical devices have been classified as Class IIa (Annex IX Rule 9) and are in
conformity with the essential requirements and provisions of Council Directive
93/42/EEC:
6000G – Hand CPM
(Marked ORMED ARTROMOT
®
-F)
W2G – Wrist CPM
(Marked ORMED ARTROMOT
®
-H)
The above devices are identical to OrthoMotion products 6000 and W2E
respectively, except for the labeling.
The EU Authorized Representative for OrthoMotion Inc. is Medical Device
Consultants International Ltd. (M.D.C.I.), Arundel House, 1 Liverpool Gardens,
Worthing, West Sussex, BN 11 1SL, United Kingdom.
The devices are subject to the procedure set out in Annex II of Directive
93/42/EEC under the supervision of
Notified Body Number 0120
,
SGS United Kingdom, Ltd., Unit 202B, Worle Parkway, Weston-Super-Mare,
North Somerset, BS22 6WA, United Kingdom.
Pickering, Ontario
September 28, 2006
Don Dorward
Director of Quality Assurance and Regulatory Affairs
OrthoMotion Inc.
OrthoMotion Inc.
901 Dillingham Road
Pickering, Ontario
L1W 2Y5 Canada
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