AMIT	SEHRA

ESSENTRAPY	LIMITED

1833	13TH AVE	APT	304

SEATTLE,	98122

EMAIL:	INFO@ESSENTRAPY.COM

												Submitted	via	www.regulations.gov

3	September 2018

Office	of	U.S.	Trade	Representative	for	Monitoring	and	Enforcement	Chair,	Section	301	

Committee	Office	of	the	U.S.	Trade	Representative	600	17th	Street	NW	Washington,	DC	

20510

Re:	Request	for	Exclusion	of	Optical	Instruments	and	Appliances,	Parts	and	Accessories,	

Others HTS	9018.90.2000,	from	the	determination	of	Action	Pursuant	to	Section	301	

Investigation	into	China's	Acts,	Policies,	and	Practices	Related	to	Technology	Transfer,	

Intellectual	Property	and	Innovation

“Essentrapy”	submits	this	request of	Exclusion	because	the	Medical	Device	that	we	

import	from	China	does	not	violate,	breach	or	Infringe	any	Practices	Related	to	

Technology	Transfer,	Intellectual	Property,	and	Innovation	that	could	affect	the	US

industry.

I. Product	In	Question

1)	Medical	Device	HTSUS	9018.90.2000	

a)	Name	of	the	Medical	Device:	Fiber	Optic	LED	Otoscope.	Model	SPECv3.	

FDA	Device Listing	#	D265010.	b)	Medical	Device	Classification	under	FDA:	

Class	I	General	Controls	874	ERA.	c)	Medical	Device	we	ask	for	Exclusion,	has

been	authorized	to	market	in	the	USA	under	FDA	Regulations.	f)	Medical	Devices	

marketed	name	is	SPECv3 g)	Medical	Device	Technical	Specifications: Otoscope	

(Handheld	optical	device	used	in	Medical)	that	is	made	up	of	a	plastic	housing	

lens,	LED	ring	and	a	lightweight	metal	body/handle.	This	device	is	used	in	

medical	practice	for	practitioners	to	examine	and	to	view	the	external	ear	canals	

of	patients	and	pets,	pediatrics	and	for	veterinary	uses.	The	device	functions	by	

illuminating	a	cone	shaped	light	from	the	head	of	the	device.	The	examiner	holds	

the	device	and	carries	out	inspections	of	the	car	by	looking	through	the	built-in	

plastic	lens.	The	device	is	powered	via	AA	cells	for	ease	of	use	and	compliancy.	

Plastic	specula	tips	are	inserted	onto	the	tip	of	the	device	as	reusable/disposable	

attachments	that	are	inserted	into	the	ear	canal.	This	device	does	not	contain	

hazardous	material	or	dangerous/small	parts.
As	we	are	a	very	small	firm	that	pride	ourselves	on	close-knit	relationships	and	trust	

with	our	consumers,	we	do	not	have	the	capital	or	resources	to	continue	business	with	

the	proposed	25%	tax	tariff.	We	will	simply	not	be	able	to	continue	doing	business	in	

the	current	economic	climate	and	will	have	to	dispose	of	the	company,	which	is	our	

biggest	fear	and	will	affect	not	only	our	livelihood	massively	but	also	our	partners	and	

clients	in	the	US.

The	manufacturing of	this	product	is	dominated	by	firms	based	in	China as	our	

manufacturer	based	in	Guangzhou	has	an	exclusive	trade	agreement	whereby	the	

SPECv3	otoscope	is	only	manufactured	for	us	to	distribute	to	consumers	in	the	US	via	

health	care	supply	chains	and	selling	online	with	FDA	governance.	100%	of	our	units	

are	part-manufactured	in	China	and	sent	to	Fort	Bragg,	CA. This	is	where	they	are	

packaged	and	forwarded	to	Seattle	for	further	inspection	and	final	manufacturing.	We	

cannot	have	a	complete	supply	without	our	supplier	in	China	and US	made	versions	of	

this	product	are	not	available	to	us.

Typically,	this	commodity	is	sold	to	small	US	owned	companies	and	healthcare	practices	

in	local	communities	across	many	states.	My	firm	is	one	of	the	leading	suppliers	of	this	

product	category	to	consumers	and	the	professional	healthcare	providers.	We	are	a	

small	family-based	firm in	Seattle employing	 20	employees.	We	have	a	huge	digital	and	

local	footprint,	engaging	with	local	businesses	and	trying	to	better	the	community	

through	our	“Hear	The	World”	scheme	that	we	participate	in	for	charitable	purposes.	

We	essentially	allow	families	and	parents	to	have	access	to	affordable	handheld	

otoscopic	devices	in	their	homes	and	practices.

We	are	classed	as	the	importer	of	devices	by	the	FDA.	We	market	just	over	3000

products a	year,	70%	of	which	are	assembled,	inspected	and	packaged	by	us	in	the	USA.	

This	category	of	product	belongs	to	the	30%	that	we	import,	inspect	and	service	but	do	

not	assemble	locally.	We	have	a	set	aside	for	the	employment	of	the	developmentally	

disabled	and	are	one	of	NYs	largest	private	employers	of	this	community. We	have	been	

established	for 3	years	under	a	business	start-up	scheme	with	aid	from	“America’s	Start	

Up	Companies	2015”	initiative.

There	are	no	viable	alternatives	to	the	China	supply	and	developing	new	sources	is	

impractical,	as	it	would	require	significant	capital	investment	AND	time	consuming	

regulatory	approval.	Even	if	possible,	it	would	take	years	to	accomplish and	is	extremely	

difficult	for	a	small	firm	like	ours.	If	the	tariff	remains,	we	would	have	to	discontinue	

these	items	to	avoid	the	losses	and	we	would	deprive	the	market	of	these important	

diagnostic	tools	and	be	forced	to	downsize,	laying	off	as	many	as	10%	of	our	staff.

This	in	turn	would	cause	higher	healthcare	prices	to	the	US	population	or	reduce	

purchases.	Like	most	products,	even	medical	instruments	are	price	elastic.	If	we are	

forced	to	pass	on	the	tariff,	effectively	raising	prices,	sales	will	suffer.	Neither	outcome	is	

good	for	my	firm,	the	industry	or	the	United	States	of	America.	It	would	not	force	us	to	

source	locally	or	even	from	other	countries	those	options	do not exist.
This	product	or	any	otoscope	manufactured	in	China	for	sale	in	US is	of	no	strategic	value	

to	Made	in	China	2025	or	other	Chinese	industrial	programs. With	no	viable	options,	we	

respectfully	ask	that	Essentrapy	be	granted	exemption	on	this	product	category.	 This	

will	not	only	help	us	but	a	large	number	of	US	based	sellers	of	Otoscopes	that	will	be	

suffering	because	of	the	new	tariffs.	

Annual	quantity	and	value	of	product	from	China

Y1	– 4,000	units, value:	$230,000

Y2	– 5,000	units, value:	$250,000

Y3	– 6,500	units, value:	$260,000

Thank	you

A	Sehra