OT:RR:BSTC:EOE H354463 JW

Mr. Hua Chen
ScienBiziP, P.C.
550 South Hope Street, Suite 2825
Los Angeles, CA 90071

VIA EMAIL: [email protected]

RE: Ruling Request; U.S. International Trade Commission; General and Limited Exclusion Orders; Investigation No. 337-TA-1364; Certain Blood Flow Restriction Devices with Rotatable Windlasses and Components Thereof

Dear Mr. Chen:

Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (“EOE Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling letter in response to Wuxi Emsrun Technology Co. Ltd.’s (“Emsrun”) 1 request for an administrative ruling, dated October 27, 2025, which included Exhibits 1-4 (collectively, “Ruling Request”). We find that Emsrun has established, through this inter partes proceeding, that its “Wuxi Tourniquet New Design 1” (“article at issue”) is not subject to exclusion from entry based on the general exclusion order (“GEO”) or limited exclusion order (“LEO”) that the U.S. International Trade Commission (“Commission”) issued in Investigation No. 337-TA-1364 (“the underlying investigation” or “the 1364 investigation”), pursuant to section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“section 337”) 2 unless and until this ruling letter is revoked or modified pursuant to 19

1 Emsrun notes that Rhino, Inc., one of the entities identified in the limited exclusion order, is Emrun’s U.S. affiliate, but was dissolved in September 2023 and the Ruling Request “does not seek permission for Rhino Inc. to import tourniquet products.” Ruling Request at 2. 2 The GEO issued in the 1364 investigation, inter alia, bars the unlicensed entry for consumption into the United States of blood flow restriction devices with rotatable windlasses and components thereof (as defined in ¶ 2 of the GEO) that infringe one or more of claims 1, 4, 15, and 16 of U.S. Patent No. 7,842,067. See Certain Blood Flow Restriction Devices with Rotatable Windlasses and Components Thereof, Investigation No. 337-TA-1364, EDIS Doc. ID 833667, General Exclusion Order (September 30, 2024) (“1364 GEO”). The LEO issued in the 1364 investigation, inter alia, bars the unlicensed entry for consumption into the United States of blood flow restriction devices with rotatable windlasses and components thereof (as defined in ¶ 2 of the LEO) that infringe U.S. Trademark Registration Nos. 3,863,064 and 5,064,378 and certain trade dress described in the complaint (see Compl. ¶ 156) and are manufactured

1 C.F.R. § 177.12. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision pertaining to section 337 exclusion orders.

As noted above, this ruling letter is the result of a request for an administrative ruling from CBP under 19 C.F.R. Part 177 that the EOE Branch conducted on an inter partes basis. The proceeding involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, Emsrun, the ruling requester; and (2) Composite Resources, Inc. and North American Rescue LLC, complainants in the 1364 investigation. See, e.g., 19 C.F.R. § 177.1(c).

Emsrun requested a ruling from CBP that its “tourniquet products bearing the design of ‘Wuxi Tourniquet New Design 1’ as identified in the photographs submitted in Exhibit 3 [of the Ruling Request], or any tourniquet products having minor variations of the same” are not subject to the 1364 GEO or 1364 LEO. See Ruling Request at 3. Various pictures 3 from Exhibit 3 of the Ruling Request are reproduced below:

abroad by, or on behalf of, or imported by or on behalf, inter alia, Rhino Inc. or any of its related entities. See Certain Blood Flow Restriction Devices with Rotatable Windlasses and Components Thereof, Investigation No. 337-TA- 1364EDIS Doc. ID 834244, Corrected Limited Exclusion Order (October 8, 2024) (“1364 LEO”). 3 We note that “confidential/attorneys eyes only” was on each of the pictures in Exhibit 3, however, it is not clear whether Emsrun was attempting to designate this as confidential information such that Emsrun is requesting that it be redacted from the published ruling. See 19 C.F.R. §§ 177.2, 177.8. Nevertheless, as noted below, if there is information in this ruling not currently bracketed in red [[ ]] that either party believes should be redacted from the published ruling, the parties are to contact CBP within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. § 177.8(a)(3).

2 3 Exhibit 3 of Ruling Request.

Emsrun also noted, inter alia, in its Ruling Request that “[b]y mid-June, 2025, the parties [ ] fully executed an agreement entitled ‘Design Around Agreement[,]’ [which provided] the relevant terms indicating Complainants’ consent for the importation of the redesigned Wuxi Tourniquet New Design 1 tourniquet model.” Ruling Request at 3.

Complainants indicated to the EOE Branch in an email (dated October 29, 2025) that they “do not contest the admissibility of the article that is the subject of Wuxi Emsrun Technology Co., Ltd.’s Part 177 ruling request.” Given that Complainants do not contest admissibility of the article at issue, the EOE Branch finds that Emsrun has established that the article at issue is not subject to the 1364 GEO or 1364 LEO. See Greenlaw v. United States, 554 U.S. 237, 243 (2008) (“In our adversary system, in both civil and criminal cases, in the first instance and on appeal, we follow the principle of party presentation. That is, we rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present.”) (emphasis added); see also Astellas Pharma, Inc. v. Sandoz Inc., 2024 U.S. App. LEXIS 23669, at *12 (Fed. Cir. 2024) (“It is for the parties—not the court—to chart the course of the litigation.”); see also Certain Robotic Floor Cleaning Devices and Components Thereof, Inv. No. 337-TA-1252, Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bonding, EDIS Doc. ID 783814 (Public) (October 7, 2022) at 10, FN 16 (“Given that [complainant] did not dispute that the [relevant] products in this category are non-infringing, this Initial Determination finds no reason to conclude otherwise.”) (emphasis added), aff’d, Notice of Commission Final Determination Finding a Violation of Section 337, EDIS Doc. ID

4 792838 (Public) (March 21, 2023) (“All findings in the FID that are not inconsistent with the Commission’s determination are affirmed.”).

If there is information in this administrative ruling not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, the parties are to contact CBP within ten (10) working days of the date of this ruling letter to indicate the same. See, e.g., 19 C.F.R. § 177.8(a)(3).

The decision above is limited to the specific facts set forth herein. If articles differ in any material way from the article at issue described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§ 177.2(b)(1), (2), (4), and 177.9(b)(1) and (2).

Sincerely,

Dax Terrill
Chief, Exclusion Order Enforcement Branch

CC: Mr. Jeffrey M. Telep
King & Spalding LLP
1700 Pennsylvania Avenue, NW
Suite 900
Washington, D.C. 20006
[email protected]

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