Declaration Of Conformity - DJO ARTROMOT K1 Classic Modo De Empleo

Declaration of conformity

In compliance with the Council Directive 93/42/EEC of 14 June 1993
concerning medical devices, the company
declares that the products of the product line
fulfill the requirements of the Council Directive 93/42/EEC of 14 June 1993,
Annex II as well as the essential requirements of Annex I.
With reference to Rule 9 of the Directive 93/42/EEC, these products are devices
of risk class IIa.
0297
Freiburg, March 15th 2010
This certificate is valid through: September 1st 2011
Annex:
ARTROMOT ® -S2 PRO
ARTROMOT ® -S3
ARTROMOT ® -S3 Comfort
ARTROMOT ® -K1
ARTROMOT ® -K2
ARTROMOT ® -K2 PRO
ARTROMOT ® -K2 PRO Chip
ARTROMOT ® -K3
ARTROMOT ® -K4
ARTROMOT ® -SP2
ARTROMOT ® -SP3
ARTROMOT ® -E2
ARTROMOT ® -E2 compact
ORMED GmbH
Merzhauser Strasse 112
D-79100 Freiburg
ARTROMOT® (see Annex)
- QA Management Representative-
49