James,

Yes, I suspected that as well, but its HTS coded as 8541410000 which is 
"Light-emitting diodes (LED)" - very appropriate, and not at all indicative of 
it being a potential emitter.

Best Regards,
-Lauren Crane
From: James Hulbert <[email protected]>
Sent: Tuesday, December 16, 2025 11:47 AM
To: [email protected]
Subject: Re: [PSES] [EXTERNAL] Re: [PSES] EMC compliance for non-emitters?

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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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