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]
On December 16, 2025 10:32:12 AM Lauren Crane
<[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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