Organization Name:

Note: Representatives submitting on behalf of an organization must enter information below.

Requestor Representative:

Section 301 Investigation: China's Acts, Policies, and Practices Related to Technology 

Transfer, Intellectual Property, and Innovation - Form to Request Exclusion of Product

When submitting a product exclusion request using this form, enter the specified 

information in the following fields and explain the basis and rationale for your statements. 

By completing this form, you certify that the information provided is complete and 

correct to the best of your knowledge. 

1. Indicate whether the comment contains business confidential information (BCI), is a public

document, or is a public version of a BCI document.

3.

2. Please provide a complete and detailed description of the product of concern:

4.

5. Requestor's relationship to the product:

CONTINUED BELOW

*

10-digit HTSUS item number* for product you wish to address in this product exclusion request:

Use numerical characters only with no special characters (example: 1023456789). For help in finding 

the HTSUS item number associated with your product, see https://hts.usitc.gov/

1

7.

6. Does this submission in regulations.gov include additional attachments?

Please indicate whether any additional attachment contains business confidential

information (BCI), is a public document, or is a public version of a BCI document.

VERSION 1

Requestor Information

Requestor Name (Last, First):

Public Document

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.

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.

9018.90.2000 Sehra, Amit Essentrapy Importer YES Public Version of BCI
END 2

8. Is this product, or a comparable product, available from sources in the United States?:

VERSION 1

11. Please provide information in support your request, taking account of the instructions

provided in Section B of the Federal Register notice (note: text entered below can extend

beyond the apparent size of this box).

9. Is this product, or a comparable product, available from sources in third countries?:

10. Please provide the value and quantity (with units) of the Chinese-origin product of concern

that you purchased for each calendar year specified. Limit this figure to the products

purchased by your firm (or by members of your trade association) alone. Please provide 

estimates if precise figures are unavailable.

2016 Value:

2015 Value:

2017 Value:

2016 Quantity:

2015 Quantity:

2017 Quantity:

NONO £260,000 6,500 $250,000 5,000 $230,000 4,000

See attached pdf.