STIMULATOR, CRAINIAL

The contract solicitation SPE2DS-26-T-073X is for the procurement of 5,000 units of the Alpha-Stim AID Cranial Electrotherapy Stimulation (CES) device, a non-drug medical device designed to safely and effectively alleviate symptoms of anxiety, insomnia, and depression. Each delivered unit must include a complete kit comprising one set of earclip electrodes, 256 additional earclip electrodes, conducting solution, two AAA batteries, a storage case, a neck lanyard, and an illustrated owner’s manual. The item is identified by NSN 6515-01-691-8183 with a unit of issue defined as a kit, and delivery is required within 20 days after order placement to the destination specified as 307 Boatner Rd Ste 1, Eglin AFB, FL 32542-1283 under FOB Destination terms. All packaging must adhere strictly to commercial standards as outlined in the procurement document, with each unit sealed in a protective container and packed in commercial exterior shipping containers suitable for safe carrier transport at the lowest possible rate; export packaging is required when applicable. Packaging and preservation must comply with DLA RP001 and MIL-STD-2073-1E, while marking must follow Medical Marking Standard No. 1 (MMS No. 1), which supersedes MIL-STD-129. Required markings include the NSN, CLIN, PRLI, quantity, and unit of issue, along with FDA-compliant labeling for electromedical devices, including establishment registration and product listing under cGMPs. The contract incorporates a broad range of federal and defense-specific clauses applicable to all medical acquisitions, including but not limited to compliance with FAR 52.246-2 for fixed-price supply inspection at destination, FAR 52.249-8 for default provisions, and FAR 52.232-39 regarding unenforceable obligations. Numerous DFARS clauses are also mandated, including those prohibiting the acquisition of items from Communist Chinese military companies, regulating export-controlled items, requiring safeguarding of covered defense information and cyber incident reporting, mandating use of U.S.-flag vessels for ocean shipments, and enforcing restrictions on hazardous materials and hexavalent chromium. Contractors must implement NIST SP 800-171 security controls and complete a DOD assessment