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12. Regulatory Information
Declaration of Conformity
The Kinesis Health Technologies QTUG product meets the relevant medical device regulations in EU and all other geographies in which it is
made available for sale. As the legal manufacturer, Kinesis Health Technologies (and its distributors) shall comply will all applicable laws and
regulations relating to medical devices, specifically the Medical Device Directive 93/42/EEC (‘MDD’) as it pertains to a Class I medical device
(without a measurement function). In the United States, QTUG meets the Quality System Regulations (‘QSR’), specifically the FDA 21 CFR part
820 for a class I medical device (exempt from 501(k) regulation).
Restrictions on Use of QTUG
THE KINESIS QTUG PRODUCT IS NOT INTENDED, DESIGNED OR AUTHORIZED FOR CONTINUOUS COMMUNICATION OF REAL TIME
DATA. THE SOFTWARE IS NOT INTENDED, DESIGNED OR AUTHORIZED FOR PROVIDING TIME-CRITICAL MEDICAL CARE, PROVIDING
MEDICAL OR OTHER EMERGENCY RESPONSE ALERTS OR ANY OTHER ANY APPLICATIONS OUTSIDE THE INTENDED USE SPECIFIED
IN THE USER GUIDE, OR FOR USE IN ANY CIRCUMSTANCE IN WHICH THE FAILURE OF QTUG WOULD PRESENT AN UNREASONABLE
RISK OF ILLNESS OR INJURY TO THE USER.
Medical Device Regulatory Compliance
QTUG is intended to measure gait and mobility parameters for automated, quantitative gait and mobility assessment during the Timed Up and Go
test, using body-worn inertial sensors. QTUG is indicated for use with patients who would benefit from assessment of mobility and falls risk.
In purchasing QTUG, the customer acknowledges and understands that the software is registered as a medical device under the Medical
Device Directive and that Kinesis may not put products ‘on sale’ without first certifying to CE conformance. Similarly, for the US, the customer
acknowledges and understands that the software is registered as a medical device under the Quality System Regulations. For such products,
the purchase and subsequent use or resale by the customer must be with Kinesis express permission and in accordance with relevant medical
device regulations.
Kinesis (or where appropriate, its local distributors) shall act as the complaint handling point of contact for any complaints relating to QTUG.
Complaints shall be defined in accordance with the MDD.
