BRACE, ANKLE

The contract specifies the procurement of 10 units of an ankle brace modeled as a dynamic stabilizer designed for medium-sized users, compatible with men’s shoe sizes 9.5 to 11 and women’s sizes 11 to 12.5. The brace is black, constructed with high-performance materials that support natural body movement, worn inside footwear, and explicitly free from natural rubber latex. Each unit must be individually sealed in a protective container and packed in commercial shipping containers suitable for safe transport via common carrier at the lowest cost to the designated delivery point. Compliance with Medical Marking Standard No. 1 is mandatory, superseding MIL-STD-129, and all packaging must adhere to DLA’s packaging requirements for medical acquisitions. The product is a Class I FDA-regulated medical device requiring registration, listing, proper labeling, and adherence to GMP standards, though a 510(k) may or may not be necessary. The item is identified by NSN 6515-01-699-6640 and part numbers AY-81-102BK-SG and 1035313, sourced from CRUZE DISTRIBUTION, LLC and SCHOOL HEALTH CORP. Delivery is due within 84 days of contract award, FOB destination, with no variance allowed in quantity. The goods are to be shipped to APO AE 09227-0000, with an initial required delivery date of April 24, 2026. The procurement is governed under solicitation SPE2DS-26-T-011U, managed by the Department of Defense’s Medical Supply Chain, with James Burke as the primary point of contact.