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Clinical Education Notice

Clinical education content is available only for US audiences.

You are leaving the ActivForce International website and will be redirected to the ActivForce US site. The webinars you are about to access may reference clinical applications, treatment concepts, or disease states.

This content does not define product use for markets outside the United States and must not be interpreted as advertising, labeling, or instructions for use in non-US regions.

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EU/EC Declaration of Conformity for CE Marking

We                                                                                                                         Activbody Inc.
4350 Executive Drive, Suite 200
San Diego, CA 92121, USA

https://www.activbody.com

declare under our responsibility, that the following product:

Model:   Activ5-M

Product name: Activforce 2
Brand name: Activbody


is in conformity with the RADIO EQUIPMENT DIRECTIVE (RED) 2014/53/EU

and the following harmonised standards and technical specifications have been applied:


HEALTH and SAFETY (article 3.1a):

1) IEC 62368-1:2014 (Second Edition): Audio/Video, information, and communication technology equipment Part1: Safety requirements, CB report

2) EU group/national differences: requirements of EN 62368-1 2014+A11:2017

3) EU RF Exposure Report according to IEC 62479:2010

 

RF SPECTRUM AND EMC (articles 3.1b and 3.2):

1)  ETSI EN 301 489-1 V2.2.3 (2019-11): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1

2) Draft ETSI EN 301 489-17 V3.2.2 (2019-12): Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17

3) RED directive: RF Testing: ETSI EN 300 328 v 2.2.2 (2019): Wideband transmission

systems; Data transmission equipment operating in the 2,4 GHz ISM band, article 3.2 of

Directive 2014/53/EU

 

RoHS and REACH COMPLIANCE:

1) RoHS Testing was successful, done according to: European Union Directive 2011/65/UE(RoHS 2) Annex II + Amendment Directive 2015/863/EU (RoHS 3) 

Note: “UE” is equivalent to English “EU”.

2) REACH Regulation  (EC) No. 1907/2006, 209 SVHC: Chemical list updated on June 25, 2020.