Legal

ISO 13485:2016 AktiiaSA

Hilo c/o Aktiia Inc, 75 State Street, Ste 100, Boston, MA, 02109, USA

Customer Support: support@hilo.com

Whatsapp: +1 (555) 971-3663

For customer support and general inquiries, please visit http://us.hilo.com/pages/contact-us or contact us at support@hilo.com or +1 (555) 971-3663.

Product Name: Hilo Backend

UDI:

UDI-DI / Device Identifier: 17649998849132

UDI-PI / Production Identifier:

Version: v2.9.0

Date of Production (Date of build of the SW): 20260126

Aktiia SA, Rue du Bassin 8a,

2000 Neuchâtel,

Switzerland

Contact:

For any questions, contact support@aktiia.com.
+41 32 552 50 58

EU Importer:

Aktiia BV

Koetshuislaan 215,

5146 BM, Waalwijk

Netherlands

Veranex Germany GmbH

Landsberger Str. 302, D-80687

Munich, Germany

Emergo Australia

201 Sussex Street, Level 20

Tower II Darling Park

Sydney, NSW 2000, Australia

Responsible for content

Laetitia Dubief
Rue du Bassin 8a
2000 Neuchâtel
Switzerland

Hosting Provider

Shopify International Limited
Victoria Buildings, 2nd Floor
1–2 Haddington Road
Dublin 4, D04 XN32
Ireland

Manufacturer information
European Authorized Representative
Australian Authorized Representative
Indicates this item is a Medical Device
Indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA) and also found on products sold outside the EEA that have been manufactured to EEA standards

Average weekly number of cuff readings according to Hilo survey of 1,337 blood pressure cuff users. For Hilo Core, actual number of measurements displayed per week may vary, as the Hilo Core App will discard readings with insufficient signal quality. Successful readings are often averaged together for easier viewing in the Hilo Core App.
Frequent errors in using BP cuffs can be as a result of body or cuff positioning, activity level before or during measurement, and many other factors. Hilo Core will not display readings when non-optimal conditions are detected, and accuracy has been demonstrated via multiple clinical trials.
Rated IP68 Water proof. The Hilo Band can be worn when dishwashing, splashing, showering or swimming. However, it cannot be used for diving or snorkeling.
In total 5 clinical trials were required during the design, development and validation of Hilo technology.
*The scientific evidence presented on this page relates to a product using the same underlying cuffless blood pressure technology as Hilo Core. Hilo Core is a wellness product and is not a medical device.

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