CLA-2-90:OT:RR:NC:N3:135

Mr. Robert Leo
Meeks, Sheppard, Leo & Pillsbury
570 Lexington Avenue, 24th Floor
New York, NY 10022

RE: The tariff classification of a peak flow meter from China.

Dear Mr. Leo:

In your letter dated June 26, 2020, you requested a tariff classification ruling on behalf of Respironics, Inc. Additional information was provided via email on June 30, 2020.

The merchandise under consideration is a Philips Respironics PersonalBest Peak Flow Meter (“Personal Best” #1024941) consisting of a plastic main body with a scale and three-zone color coded indicators, a plastic top cover, and a plastic bottom hinged cover that can be folded into a handle. The peak flow meter is a measuring and monitoring device. It monitors lung function and measures the Peak Expiratory Flow (PEF) speed at which air is expelled from the lungs. PEF measurements are an essential tool in gauging how well the user’s lungs and airways are working. The device can be used by a clinician to monitor the patient’s expiratory breath in a clinical setting; however, it is primarily used by the patient for self-monitoring.

You propose classification of the peak flow meter in subheading 9018.19.9550, Harmonized Tariff Schedule of the United States (HTSUS), which provides for other electro-diagnostic apparatus. Although it is a diagnostic device, it does not involve the use of electricity; therefore, it will be classified elsewhere.

The applicable subheading for the Philips Respironics PersonalBest Peak Flow Meter will be 9018.90.8000, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: [o]ther instruments and appliances and parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free.

You also request consideration of the peak flow meter under the Nairobi Protocol. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982, established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. These tariff provisions specifically state that "[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons: parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing article" are eligible for duty-free treatment. U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS, states that, "the term 'blind or other physically or mentally handicapped persons' includes any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one's self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working."

U.S. Note 4(b), subchapter XVII, Chapter 98, HTSUS, which establishes limits on classification of products in these subheadings, states as follows: (b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover-- (i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or (iv) medicine or drugs.

Although we agree that the peak flow meter used primarily by asthmas patients is an article specially designed or adapted for the use or benefit of the physically handicapped persons according to the analysis in Headquarter Ruling H301481 (June 14, 2019), we need to determine if any of the U.S. Note 4(b) exclusions apply to the device. In Sigvaris, Inc. v. United States, Slip Op. 17-60 (Ct. Int’l Trade 2017), the court cited a dictionary definition of “[d]iagnostic.” It states “[d]iagnostic is defined as ‘serving to distinguish, identify, or determine [a] characteristic of or … the presence of a particular disease.’ See Webster’s Third New International Dictionary 622 (unabr. 2002).” The peak flow meter monitors lung function and measures the PEF speed. Based on online research, “the regular collection of a patient’s PEF can help determine if the airways of the patient are narrowing … PEF testing can be performed as a means of early detection of potential asthma attacks.” “Spirometers and peak flow meters are perhaps some of the most widely used devices when it comes to the diagnosis and management of common respiratory diseases such as asthma, COPD and cystic fibrosis.” Just as spirometers are specifically listed as an example of diagnostic instruments and apparatus in the Explanatory Note (I) (B) (4) to heading 9018, the peak flow meter is also a diagnostic instrument. Therefore, we conclude that the peak flow meter is excluded from subheading 9817.00.96 per the U.S. Note 4(b) (iii) to subchapter XVII, Chapter 98, HTSUS.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Fei Chen at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division