CLA-2-64:OT:RR:NC:N2:247

Ms. Iris Long
Russell A. Farrow, Ltd.
475A Admiral Blvd.
Mississauga, L5T 2N1
Canada

RE: The tariff classification of footwear insoles from Canada Dear Ms. Long:

In your letters dated April 11, 2022, and June 1, 2022, you requested a tariff classification ruling on behalf of your client, Orpyx Medical Technologies, Inc. You have submitted descriptive literature, diagrams, photographs, and marketing materials for two styles of footwear insoles. No samples were submitted with your request.

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 your letter, you suggest that the Orpyx SI® Flex Sensory Insoles and Orpyx SI® Custom Sensory Insoles are classified under subheading 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), as orthopedic appliances. We disagree. Note (6) to Chapter 90 states “[f]or the purposes of heading 9021 … [o]rthopedic appliances include footwear and special insoles designed to correct orthopedic conditions, provided that they are either (1) made to measure or (2) mass-produced, entered singly and not in pairs and designed to fit either foot equally.” In this case, both types of insoles help individuals, who may or may not have a pre-existing diabetic foot ulcer, to manage and prevent diabetic foot ulcers. They are not designed to correct orthopedic conditions. In addition, the Flex Sensory Insoles are mass produced, presented in pairs, and made in left and right configurations that are not designed to fit either foot equally. Although one of the foam layers of the Custom Sensory Insoles can be modified to accommodate various special requirements such as depressions for offloading and may be considered made to measure, they do not correct orthopedic conditions. As such, they will not be classified in heading 9021, HTSUS.

The applicable subheading for the Orpyx SI® Flex Sensory Insoles and Orpyx SI® Custom Sensory Insoles will be 6406.90.3060, HTSUS, which provides for parts of footwear; other: removable insoles, heel cushions and similar articles; of rubber or plastics; other. The rate of duty will be 5.3 percent ad valorem.

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 Stacey Kalkines at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division