Individual Unit, Clinical Bundle
User Manual mTrigger
™ Biofeedback System | V2-d3 | 03-01-21
Page 22 of 27
Caution:
Water coming in contact with sensing electrodes may impact skin
conductance and thereby signal quality.
7 | Quality and Regulatory
7.1: Quality Environment
•
The mTrigger
®
biofeedback system production environment complies with
21CFR820.70
•
The mTrigger
®
biofeedback system is manufactured in compliance with the United
States Food and D
rug Administration’s general manufacturing practices
concerning medical devices.
7.2: Regulatory Compliance
According to the applicable standards, the mTrigger
™ Biofeedback System is classified
as follows:
•
Class II Medical Device per USFDA 21CFR 882.5050
•
510(k) exempt
In order to safely perform its intended use, the system requires two accessories whose
classifications and registrations are as follows:
•
Custom Sensing Electrodes
– Cutaneous electrodes classified as Class II (special
controls; 510(k) exempt) per USFDA 21CFR Sec. 882.1320
•
Custom Sensing Cables
– not classified as a medical device or medical device
accessory; tested as part of the mTrigger
®
Biofeedback System EMC and safety
standards
Please see supplemental FDA Compliance Summary Report (Quality Document number
Q-06) for further details.
8 | Specifications and Environmental Conditions
8.1: Specifications
Table 8.1 System Specifications
Model Name
mTrigger
®
Biofeedback System
Model Number(s)
863712000337 - Individual Unit + Accessories
863712000382 - Clinical Bundle
