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Kinesia one and kinesia 360

Official notice

22 Apr 2025

Last checked

22 Apr 2025

Medium riskHealth Canada

An official Health Canada notice concerns Kinesia one and kinesia 360. The Kinesia ONE and Kinesia 360 products are being recalled because they were incorrectly sold as class I devices but should have been classified as class II devices, and thus do not have valid Medical Device Licenses (MDL). Recall Start Date: March 28, 2025 Published 2025-04-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77312

Official notice

2025-04-22

The hazard

The Kinesia ONE and Kinesia 360 products are being recalled because they were incorrectly sold as class I devices but should have been classified as class II devices, and thus do not have valid Medical Device Licenses (MDL). Recall Start Date: March 28, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77312

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Affected products

Product 1

Affected products - Kinesia ONE, Lot or serial number - Not applicable., Model or catalog number - 700-0019

Product 2

Affected products - Kinesia 360, Lot or serial number - Not applicable., Model or catalog number - 700-0020

Risk / hazard

The Kinesia ONE and Kinesia 360 products are being recalled because they were incorrectly sold as class I devices but should have been classified as class II devices, and thus do not have valid Medical Device Licenses (MDL). Recall Start Date: March 28, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Great Lakes Neurotechnologies, Kinesia One And Kinesia 360.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77312

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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