CLA-2 RR:CR:GC 961734 RTR
Ms. Kristin Dilwirth
Balance Systems, Inc.
18645 SW Farmington Road, Suite 283
Aloha, Oregon 97007
RE: Device for rehabilitation of carpal tunnel syndrome and
repetitive stress injuries; NY C85565 revoked.
Dear Ms. Dilwirth:
This is in response to your April 24,1998, appeal of NY
C85565, dated March 25, 1998, regarding the tariff classification
of "Flextend" under the Harmonized Tariff Schedule of the United
States (HTSUS), said to be a therapeutic product designed to
assist in prevention and rehabilitation of carpal tunnel syndrome
and other repetitive stress injuries of the fingers, hand, wrist
and elbow.
FACTS:
According to your letter and supporting documents,
"Flextend" is packaged in Hong Kong and China, and includes a
U.S.-made rubber tubing component. It is registered with the
U.S. Food & Drug Administration (FDA) as a Class 1 good (as
described under "Law and Analysis" below). The merchandise is
also registered with the U.S. Patent Office as a "medical
device". It is prescribed by physicians to patients for the
prevention and rehabilitation of carpal tunnel syndrome and
repetitive stress injuries of the fingers, hand, wrist and elbow.
You state that its patented design allows several specific carpal
tunnel syndrome neutralizing exercises to be performed
simultaneously. "Flextend" addresses carpal tunnel syndrome by
equalizing the muscle imbalance ratio between the flexors and
extensors, and stabilizing the finger, hand, wrist, and elbow
joints, which are at the root of median-nerve compression within
the carpal tunnel. The cost of "Flextend" is covered by most
major insurance companies. Customs has liquidated the
merchandise is subheading 9019.10.20, HTSUS.
ISSUE:
Whether a device for rehabilitation of carpal tunnel
syndrome and repetitive stress injuries of fingers, hands, wrists
and elbows is classifiable in subheading 9019.10.20, HTSUS, as a
mechano-therapy appliance, or in subheading 9506.91.0030, HTSUS,
as equipment for general physical exercise; other.
LAW AND ANALYSIS:
Merchandise is classifiable under the HTSUS in accordance
with the General Rules of Interpretation (GRIs). GRI 1 states in
part that for legal purposes, classification shall be determined
according to the terms of the headings and any relative section
or chapter notes, and provided the headings or notes do not
require otherwise, according to GRIs 2 through 6.
The provisions under consideration are as follows:
9019 Mechano-therapy appliance; massage apparatus;
psychological aptitude testing apparatus; ozone
therapy, oxygen therapy, aerosol therapy
artificial respiration or other therapeutic
respiration apparatus; parts and accessories
thereof:
9019.10 Mechano-therapy appliances; massage
apparatus; psychological aptitude testing
apparatus; parts and accessories thereof:
9019.10.20 Mechano-therapy appliances; massage
apparatus; parts and accessories
thereof.
* * * *
9506 Articles and equipment for general physical
exercise, gymnastics, athletics, other sports
(including table-tennis) or outdoor games, not
specified or included elsewhere in this chapter;
swimming pools and wading pools; parts and
accessories thereof:
Other:
9506.91.00 Articles and equipment for general
physical exercise, gymnastics or
athletics; parts and accessories
thereof:
9506.91.0030 Other.
* * * *
21 C.F.R. 860.3(c)(1) provides in pertinent part:
"Class means one of three categories of regulatory
control for medical devices defined below: Class 1
means the class of devices that are subject to only the
general controls authorized by or under sections 501
(adulteration), 502 (misbrandings), 510 (registration),
516 (banned devices), 518 (notification and other
remedies), 519 (records and reports), and 520 (general
provisions) of the act. A device is in class I if (i)
general controls are sufficient to provide reasonable
assurance of the safety and effectiveness of the
device, or (ii) there is sufficient information from
which to determine that general controls are sufficient
to provide reasonable assurance of the safety and
effectiveness of the device or to establish special
controls to provide such assurance, but the device is
not life-supporting or life-sustaining of for a use
which is of substantial importance in preventing
impairment of human heath, and which does not present a
potential unreasonable risk of injury."
In NY C85565, dated March 25, 1998, Customs classified
"Flextend" in subheading 9506.91.0030, HTSUS, the provision for
Articles and equipment for general physical exercise... Other.
You contend that "Flextend" is classifiable under subheading
9019.10.20, HTSUS, the provision for mechano-therapy appliances.
In support of your appeal, you claim that "Flextend" was
expressly designed for the treatment of carpal tunnel syndrome
and other musculoskeletal disorders, and that it is recognized by
physicians and other health care professionals, and by major
insurance companies, as an effective tool for the rehabilitation
and prevention of these ailments.
The Harmonized Commodity Description And Coding System
Explanatory Notes (ENs) constitute the official interpretation of
the Harmonized system. While not legally binding on the
contracting parties, and therefore not dispositive, the ENs
provide a commentary on the scope of each heading of the
Harmonized System and are thus useful in ascertaining the
classification of merchandise under the System. Customs believes
the ENs should always be consulted. See T.D. 89-80, 54 Fed. Reg.
35127, 35128 (Aug. 23, 1989).
EN 90.19(I) states:
"These appliances are mainly used to treat
diseases of the joints or muscles, by
mechanical reproduction of various movements.
It should be noted that such treatment is
usually carried out under medical
supervision; the apparatus of this heading
should therefore be distinguished from the
ordinary physical culture or medical
exercising equipment designed for use in the
home or in specially equipped premises..."
Accordingly, devices for ordinary physical culture or medical
exercising equipment designed for use in the home or in specially
equipped premises, such as a dumbbells or hand squeezing
apparatus, are not classifiable in heading 9019, HTSUS, because
they are not appliances mainly used to treat diseases of the
joints or muscles, by mechanical reproduction of various
movements.
"Flextend" is distinguishable from ordinary physical culture
or medical exercising equipment for a variety of reasons. As
discussed above, (1) it is specifically designed for prevention
or rehabilitation of carpal tunnel syndrome and repetitive stress
injuries of the finger, hand, wrist, and elbow; (2) it is sold to
physicians and physical and occupational therapists; (3) its
treatment is carried out under medical supervision; (4) it is
sold as a prescription product, whose cost is covered by major
insurance companies; and (5) it is classified by the F.D.A. as a
"medical device." Thus, the merchandise is more specifically
described in subheading 9019.10.20, HTSUS, which provides for
mechano-therapy appliances, than in the basket provision
9506.91.0030, HTSUS, for articles and equipment for general
physical exercise.
HOLDING:
Under the authority of GRI 1, "Flextend" is classifiable in
subheading 9019.10.20, HTSUS, the provision for mechano-therapy
appliances.
EFFECT ON OTHER RULINGS:
NY C85565, dated March 25, 1998, is revoked.
Sincerely,
John Durant, Director
Commercial Rulings Division