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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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ActivBody REACH SVHC Disclosure

The Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation EC 1907/2006, commonly referred to as REACH, is a European regulation on chemicals and their safe use. Under Article 33 of REACH, suppliers of articles containing Substances of Very High Concern (SVHCs) above 0.1% by weight are required to provide sufficient information to allow safe use of the article, including at minimum the name of the substance.

Based on the current version of the ECHA Candidate List for Authorization, the following ActivBody product contains an SVHC above the disclosure threshold of 0.1% by weight:

SVHC CAS Number Application / Location Product
Lead 7439-92-1 Metal alloy (internal mechanical parts)* ActivForce 2 (Model: Activ5-M, ActivM2)

* Use of lead in copper alloy (brass) mechanical components is exempt under EU RoHS Directive 2011/65/EU, Annex III, Exemption 6(c) (lead as an alloying element in copper alloys up to 4% by weight). The presence of lead above the REACH disclosure threshold of 0.1% by weight triggers Article 33 disclosure obligations independently of any RoHS exemption.

Safe Use Information

Lead is present in internal metal alloy mechanical components and is not accessible under normal conditions of use or reasonably foreseeable misuse. The SVHC does not pose a safety risk to users during normal use of the ActivForce 2 device. Users should not attempt to disassemble the device. At end of life, the device should be disposed of in accordance with local WEEE regulations and not placed in unsorted municipal waste.

Information to Downstream Users and Consumers

In accordance with Article 33(2) of REACH, this information is made available upon request to any consumer within 45 days of receiving the request at no charge. EU distributors and importers of ActivBody products are responsible for ensuring this disclosure is passed along the supply chain and for fulfilling any applicable obligations under the EU Waste Framework Directive, including notification to the ECHA SCIP database.

ECHA SCIP Database

Information about ActivBody products that contain a REACH Candidate List substance above the disclosure threshold of 0.1% by weight is publicly available in the ECHA SCIP database at https://echa.europa.eu/scip.

Contact

For questions regarding this disclosure or to request SVHC information as a consumer, please contact: support@activbody.com

This disclosure reflects the ECHA Candidate List as of May 2025. ActivBody reviews this disclosure periodically and updates it as new substances are added to the Candidate List. © 2025 ActivBody, Inc. All rights reserved.