OT:RR:CTF:FTM H330775 TSM
Ms. Iris Long
Russell A. Farrow Limited
Farrow Consulting
475A Admiral Blvd.
Mississauga, ON L5T 2N1
Canada
RE: Affirmation of NY N326427; Tariff classification of footwear insoles
Dear Ms. Long:
This is in response to your request, dated October 4, 2022, for reconsideration of New York Ruling Letter ("NY") N326427, issued to your client, Orpyx Medical Technologies Inc., on June 23, 2022. In that ruling, U.S. Customs and Border Protection ("CBP") found that the Orpyx SI Flex Sensory Insoles and Orpyx SI Custom Sensory Insoles were classified under subheading 6406.90.30, Harmonized Tariff Schedule of the United States ("HTSUS"), which provides for "Parts of footwear (including uppers whether or not attached to soles other than outer soles); removable insoles, heel cushions and similar articles; gaiters, leggings and similar articles, and parts thereof: Other: Of other materials: Of rubber or plastics: Other." We have reviewed NY N326427, determined that it is correct and for the reasons set forth below, we affirm NY N326427.
NY N326427 described footwear insoles at issue as follows:
The Orpyx SI Flex Sensory Insoles and Orpyx SI Custom Sensory Insoles are removable footwear insoles available to men and women in a full complement of shoe sizes. In your correspondence, you state the insoles are not available in retail establishments and are targeted to patients of podiatrists. The Orpyx SI Flex Sensory Insoles are constructed in three layers and the Orpyx SI Custom Sensory Insoles, which might be prescribed for those needing additional foot support, are constructed with an additional foam layer that can be molded. The base layer of both versions is composed of Ethylene-vinyl acetate (EVA) to provide durability. The next layer incorporates the OSI Sensory System consisting of multiple pressure and temperature sensors (27-37 sensors depending upon insole size), 6-axis IMUs that utilize accelerometers, gyroscopes, etc., and Cellular and Bluetooth transmitters. The top foam layers consist of rubber/plastics such as EVA and polyurethane covered with a microfiber lining. The insoles are packed with charging wires, enabling a weekly or biweekly charge.
When the insoles are worn, both versions collect physiologic data such as wear-time, pressure, step count, orientation, and temperature while the user performs their daily activities. The data analytics gathered is transmitted via cellular and Bluetooth technology to the internet. Data patterns can be accessed and monitored by phone, tablet, computer, etc., by the wearer and medical professionals with the goal of effective decision-making regarding designing care plans to manage, and to possibly prevent, diabetic foot ulcers and other foot problems.
In the request for reconsideration, the requestor argued that the primary function of the sensory insoles is to monitor a user's physiological parameters, such as plantar pressure, step count, hours of use and temperature, and in turn alert the user to possible injury to the foot, and that based on this primary function the footwear insoles are provided for in Chapter 90, HTSUS. [1] The requestor expressed that this is consistent with the Explanatory Notes ("ENs") to Chapter 90, which provide in relevant part that Chapter 90 includes instruments and appliances for medical, surgical, dental, or veterinary uses, or for related purposes. According to the request, the sensory insoles under consideration are registered under the FDA Medical Devices System as medical devices. [2] Further, the requestor notes that the sensory insoles meet the terms of heading 9018, HTSUS, because EN 90.18 provides that this heading covers electro-medical apparatus for preventive, curative, or diagnostic purposes, and includes electro-diagnostic apparatus such as diagnostic apparatus incorporating or operating in conjunction with an automatic data processing machine for processing and visualizing clinical data, etc. Specifically, it is the requestor's position that the sensory insoles are "other patient monitoring systems" classified in subheading 9018.19.5500, HTSUSA, which provides for "Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Patient monitoring systems." [3]
Heading 9018, HTSUS, is a use provision which provides for instruments and appliances used in medical, surgical, dental, or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments. Additional U.S. Rule of Interpretation 1(a), HTSUS, states that in the absence of special language or context which otherwise requires, a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use.
EN 90.18 provides, in relevant part:
This heading covers a very wide range of instruments and appliances which, in the vast majority of cases, are used only in professional practice (e.g., by doctors, surgeons, dentists, veterinary surgeons, midwives), either to make a diagnosis, to prevent or treat an illness or to operate, etc.
With regard to instruments or appliances used in medical sciences and classified in heading 9018, CBP's position is that these instruments include those that have been designed to capture data that directly points to medical diagnoses or physiological parameters needed to diagnose. See NY N141415, dated January 31, 2011 (classifying a mobile health system component created for the healthcare industry and consisting of an electro-cardiogram (ECG) device, a blood pressure meter, a peak flow meter (for lung capacity), a pulse oximetry sensor (for blood oxygen saturation), and a digital weight scale, which are all devices designed to measure patients' vital signs, in heading 9018, HTSUS); NY N289886, dated September 28, 2017 (classifying wearable and reusable sensor patches intended to collect, among other parameters, physiological data such as heart rate, heart rate variability, and respiration rate, to be transmitted through WiFi or a cellular network for use by medical practitioners, in heading 9018, HTSUS).
Upon review, we find that the sensory insoles at issue are not classified in heading 9018, HTSUS, as instruments or appliances used in medical sciences. While the insoles collect data points such as wear-time, pressure, step count, orientation, and temperature, which might provide information to a medical professional that a further investigation is necessary, these are not physiological parameters that directly point to medical diagnoses. In this regard, the sensory insoles under consideration differ from the devices at issue in NY N141415 and NY N289886, which were designed to measure vital signs such as blood pressure, lung capacity, blood oxygen saturation, heart rate, and respiration rate, which point directly to a diagnosis of diseases or ailments. Therefore, we find that the sensory insoles at issue in NY N326427 are not instruments or appliances used in medical, surgical, dental or veterinary sciences, of heading 9018, HTSUS.
Accordingly, we affirm NY N326427, dated June 23, 2022, which correctly classified the Orpyx SI Flex Sensory Insoles and Orpyx SI Custom Sensory Insoles under subheading 6406.90.30, HTSUS.
Sincerely,
Yuliya A. Gulis, Director
Commercial and Trade Facilitation Division
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[1] See HQ H303881, dated April 30, 2021 (finding that wireless exchange of data between monitoring or measuring apparatus and a host device is a support or secondary function).
[2] See HQ 085064, dated August 24, 1990 (finding that classification as a medical device by the FDA has no binding effect on classification by CBP).
[3] We note that the subheading text providing for "Patient monitoring systems" does not govern the scope of the four-digit heading. Therefore, only merchandise classified under heading 9018, HTSUS, can be considered for classification as a "Patient monitoring system" under subheading 9018.19.5500, HTSUSA.