Well, not if the wrong HS Tarriff code was entered in the documentation for the 
device. I could see how LED acronym could easily be confused a "Laser" Emitting 
Diode device instead of Light


Larry K. Stillings
Compliance Worldwide, Inc. 
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-----Original Message-----
From: Ralph McDiarmid <[email protected]> 
Sent: Tuesday, December 16, 2025 1:34 PM
To: [email protected]
Subject: Re: [PSES] [EXTERNAL] Re: [PSES] EMC compliance for non-emitters?

In other words, incompetence or at least a lack of effective training.

 

From: James Hulbert <[email protected]
<mailto:[email protected]> > 
Sent: December 16, 2025 9:47 AM
To: [email protected] <mailto:[email protected]> 
Subject: Re: [PSES] [EXTERNAL] Re: [PSES] EMC compliance for non-emitters?

 

Or....I suspect the broker flagged FDA because it is an LED device and they
confused it with a Laser device.

 

Jim Hulbert

 

 

From: Jim Bacher, WB8VSU <[email protected] <mailto:[email protected]> > 
Sent: Tuesday, December 16, 2025 12:29 PM
To: [email protected] <mailto:[email protected]> 
Subject: [EXTERNAL] Re: [PSES] EMC compliance for non-emitters?

 

This message is from an EXTERNAL EMAIL system. Use caution and think before
opening attachments, clicking links, or responding.

Lauren, there are a lot of small companies that do not have Compliance
Engineers or legal departments to fact check statements and documents. So
they ended up duplicating what someone else has done without any
understanding of what it means. As long as they are not caught, they can get
away with it. 

 

The broker is in error for flagging it for FDA. I would return the form
tagged as NA (not applicable) along with a letter stating the device is not
for intended for medical use and the standards apply to non medical devices
as well as medical devices. 

 

 

Jim Bacher, WB8VSU 

[email protected] <mailto:[email protected]> 

 

 

On December 16, 2025 10:32:12 AM Lauren Crane
<[email protected]
<mailto:[email protected]> > wrote:

Dear Experts, 

 

I have a weird Customs challenge. I am trying to import to the US an LED
indicator wrapped up in a small case etc... it is a part of a company's
switch line up. It is essentially a lighted (LED) single pole switch block
for a pushbutton, rated to operate at 24 V AC/DC. 

 

The OEM has declared the following compliance :

*       Resistance to fast transients 2 kV IEC 61000-4-4 
*       Resistance to electromagnetic fields 9.1 V/m (10 V/m) IEC 61000-4-3 
*       Resistance to electrostatic discharge 6 kV on contact (on metal
parts) IEC 61000-4-2 8 kV in free air (in insulating parts) IEC 61000-4-2 
*       Electromagnetic emission Class B IEC 55011

 

This gives it the appearance as an item of EMC-interest, thus triggering
(apparently) the import broker to flag it for the FDA import form 2877. 

 

My question is why would the switch OEM company do this? I can see why ESD
and fast transients might be of interest to a switch, but why say it is
compliant to an emission standard when the item in and of itself is not an
emitter? I'm nearly certain it is compliant to the cited standard because it
has no emissions of its own at all. 

 

Similarly one could declare these compliances for a length of insulated
conductor, but it really makes no sense to do so. 

 

It does operate off of 24V AC and DC, but I doubt there are any active
components doing power conversion internally. 

 

Thanks in advance for any insights you might have....

 

Best Regards, 

-Lauren Crane


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