Quality And Regulatory; Quality Environment; Regulatory Compliance; Specifications And Environmental Conditions - mTrigger Biofeedback User Manual

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
21CFR820.70
• The mTrigger
States Food and Drug 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
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
Model Number(s)
Individual Unit, Clinical Bundle
®
biofeedback system production environment complies with
®
biofeedback system is manufactured in compliance with the United
®
mTrigger
863712000337 - Individual Unit + Accessories
863712000382 - Clinical Bundle
User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21
®
Biofeedback System EMC and safety
Biofeedback System
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