Classification and eligibility for duty-free treatment under Nairobi Protocol concerning certain parts of robotic medical device from China

N361169May 29, 2026CLA-2-85:OT:RR:NC:N2:207 CATEGORY: Classification TARIFF NO.: 9019.10.2090; 8501.31.2000; 8501.31.4000 Ms. Paula ConnellySandler, Travis & Rosenberg, P.A.100 Trade Center, Ste. G-700Woburn, MA 01801RE: Classification and eligibility for duty-free treatment under Nairobi Protocol concerning certain parts ofrobotic medical device from ChinaDear Ms. Connelly:In your letter dated April 30, 2026 , you requested a rulingon the eligibility of a robotic medical device underbehalf of your client, Barrett Technology. the Nairobi Protocol on The items under consideration are described as components for BURT® (Barrett Upper-extremity RoboticTrainer) which is a specialized rehabilitation robot to assist patients with upper limb impairments resultingfrom neurological traumas such as stroke, traumatic brain injury (TBI), spinal cord injury (SCI), andParkinson’s disease. These conditions often lead to hemiparesis or hemiplegia, muscle contractures, sensory,and cognitive impairments, which must be diagnosed by medical professionals. Patients are referred toinpatient or outpatient rehabilitation facilities by physicians, and approval for these expensive services is onlygranted when patients are experiencing actual impairment. BURT® enables patients to practice basic armmovements with a weightless limb while engaging in simple digital activities. The system trains the brainand arm to perform everyday tasks such as punching, turning, lifting, or sorting laundry by interacting withBarrett-developed software and the weight-levitating robotic arm.The Outer Link (Part Number M0930) is a structural component of the BURT® robotic arm, made primarilyof aluminum. It supports the patient by countering gravity, enabling movement and participation inrehabilitation activities. This specially designed part allows patients to move the robotic arm and engagewith therapeutic exercises, helping them develop new neural pathways through brain plasticity. The OuterLink is exclusively designed and manufactured for use with the BURT® system.The Motor Assemblies (Part Numbers M0898, M0999, and M1063) are mainly comprised of rare earthmagnets, copper, and steel, encased in aluminum housings. They provide mechanical actuation of the three active joints in the robotic arm. The robotic arm would be inoperable without the motor assemblies as theyenable the motion necessary for patient interaction. You state that the motors are proprietary to the BURT®system and have no other application.The Lifting Column (Part Number M0911) is an aluminum column that integrates internal electronics and amotor. It serves as a stable base facilitating the vertical adjustment of the robotic arm to suit varying patientconfigurations. This component is critical as its absence would confine the trainer to a fixed height,preventing its use with different patients in multiple settings. The lifting column is a specially designedcomponent used exclusively within the Burt® robotic trainer.The applicable subheading for the Outer Link (Part Number M0930) will be 9019.10.2090, HarmonizedTariff Schedule of the United States (HTSUS), which provides for “parts and accessories of mechano-therapyappliances and massage apparatus.” The general rate of duty will be Free.The applicable subheading for the Motor Assemblies ,(Part Numbers M0898, M0999, and M1063) will be8501.31.2000, HTSUS, which provides for “Electric motors…: Other DC motors; DC generators: Of anMotors: Exceeding 37.5 W but not exceeding 74.6 W.The general rate ofoutput not exceeding 750 W: ” duty will be 2.8 percent ad valorem.The applicable subheading for the Lifting Column will be 8501.., HTSUS,(Part Number M0911)314000which provides for “Electric motors and generators (excluding generating sets): Other DC motors; DCgenerators, other than photovoltaic generators: Of an output not exceeding 750W: Motors: Exceeding 74.6 W but not exceeding 735 W.”The general rate of duty will be 4 percent ad valorem .In your submission you requested consideration of a secondary classification for the subject parts for under 9817.00.96, HTSUS, which applies to articles and parts of articles specificallyBURT® systemdesigned or adapted for the use or benefit of the permanently or chronically physically or mentallyhandicapped.Chapter 98, Subchapter XVII, U.S. Note 4(a), HTSUS, defines the term blind or other physically or mentally handicapped persons as including “any person suffering from a permanent or chronicphysical or mental impairment which substantially limits one or more major life activities, such as caring forone’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.As noted in your submission, the BURT® system is primarily used for stroke patients and those with braininjury, spinal cord injury, or Parkinson’s disease. It is designed to address upper limb impairments resultingfrom these conditions. While the BURT® system cannot reverse brain injury or neurological disease, therobotic therapy provides repetitive training that stimulates neuroplasticity, improves and restores musclestrength and coordination, and enhances recovery outcomes. It can significantly improve motor function andquality of life for patients.Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of theblind or other physically or mentally handicapped persons; parts and accessories (except parts andaccessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in theforegoing articles . . . Other.” The term “blind or other physically or mentally handicapped person” includes“any person suffering from a permanent or chronic physical or mental impairment which substantially limitsone 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(a), Subchapter XVII, Chapter 98, HTSUS.Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnosticarticles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extentgreater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Wemust first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appealsfor the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” themerchandise “must be intended for the use or benefit of a specific class of persons to an extent greater thanfor the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection(CBP):(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable byproperties of the design, form, and the corresponding use specific to this unique design, from articlesuseful to non-handicapped persons); (2) whether any characteristics are present that create asubstantial probability of use by the chronically handicapped so that the article is easilydistinguishable from articles useful to the general public and any use thereof by the general public isso improbable that it would be fugitive; (3) whether articles are imported by manufacturers ordistributors recognized or proven to be involved in this class or kind of articles for the handicapped;(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)whether the condition of the articles at the time of importation indicates that these articles are for thehandicapped.It is our opinion that the BURT® system is a therapeutic article. Consistent with HQ ruling H285358(August 6, 2018), the courts and CBP have consistently held that therapeutic articles are those whose purposeis the complete or partial elimination of disease, and the BURT® system falls within this category. See Travenol Laboratories, Inc. v. United States, 17 CIT 69 (1993); Richards Medical Co. v. United States, 720F. Supp. 998 (CIT 1989), aff'd, 910 F.2d 828 (Fed. Cir. 1990). As such, the BURT® system is precludedfrom duty-free treatment under subheading 9817.00.96, HTSUS, per U.S. Note 4-b-iii to Subchapter XVII ofChapter 98. Consequently, the Outer Link (Part Number M0930), Motor Assemblies (Part Numbers M0898,M0999, and M1063), and Lifting Column (Part Number M0911) are not eligible for duty-free treatmentunder the Nairobi Protocol.The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenienceand are subject to change. The text of the most recent HTSUS and the accompanying duty rates are providedat https://hts.usitc.gov/.This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to theclassification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs.For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.The holding set forth above applies only to the specific factual situation and merchandise description asidentified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.Additionally, we note that the material facts described in the foregoing ruling may be subject to periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Howard Suh at howard.suh@cbp.dhs.gov. Sincerely, (for)James P. ForkanDirectorNational Commodity Specialist Division