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NEUROMETRIX INC. DOES NOT ACCEPT LIABILITY BEYOND THE REMEDIES SET FORTH IN THIS WARRANTY
STATEMENT OR LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT
LIMITATION ANY LIABILITY FOR PRODUCTS NOT BEING AVAILABLE FOR USE OR FOR LOST DATA OR
SOFTWARE.
These provisions apply to NeuroMetrix's limited one-year warranty only.
4.6 Service
Should the NC-stat DPNCheck device require service, contact NeuroMetrix Customer Service at (888)
786-7287. When you call NeuroMetrix to request service, please be prepared to provide the following
information:
•
Serial number
•
Description of the problem
Do not return any component of the NC-stat DPNCheck device without first obtaining a Return Material
Authorization (RMA) Number from Customer Service. Be sure that this number is clearly visible on the
exterior of the return package. If a NC-stat DPNCheck device component must be shipped to a service
center, pack it in the original shipping container or in packaging which provides enough protection to
prevent damage during shipment.
4.7 FDA Notification
The NC-stat DPNCheck device is manufactured in compliance with the U.S. Federal Quality System
Regulation (21 CFR Part 820). As a health care provider, you may have responsibilities under the Safe
Medical Devices Act (SMDA) for reporting to NeuroMetrix, and possibly the FDA, the occurrence of
certain events. (FDA reportable events are detailed in 21 CFR Part 803.)
In accordance with our Quality System, NeuroMetrix should be notified of any device failures or
malfunctions. Issues encountered should be reported to NeuroMetrix Customer Service. Outside of the
United States, problems should be reported to the nearest NC-stat DPNCheck device distributor. This
information will help ensure that NeuroMetrix continues to provide products and services of the highest
possible quality.
12
NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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