Ohms law
Senior Member
- Location
- Sioux Falls,SD
Need help! Local inspector is failing final inspection due to Sonendo "GentleWave System" not having a NRTL label.
Manufacture states " is a medical device cleared by the FDA and subject to IEC/EN60601, it does not fall within scope of UL 61010-1 (Safety Requirement for Electrical Equipment for Measurement, Control, and Laboratory used part 1: General Requirements). Therefore the specific equipment is not subject to labeling.
There is no lableling, the company is stating that it is allowed to be provided with in literature with equipment and not subject to labeling like a typical NRTL label. Any advice with supporting argument would be amazing right about now!
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Manufacture states " is a medical device cleared by the FDA and subject to IEC/EN60601, it does not fall within scope of UL 61010-1 (Safety Requirement for Electrical Equipment for Measurement, Control, and Laboratory used part 1: General Requirements). Therefore the specific equipment is not subject to labeling.
There is no lableling, the company is stating that it is allowed to be provided with in literature with equipment and not subject to labeling like a typical NRTL label. Any advice with supporting argument would be amazing right about now!
Sent from my SM-G930V using Tapatalk