STIMULATOR, CRAINIAL ELECTROTHERAPY

The solicitation seeks the procurement of 2,000 Alpha-Stim AID Kits, each containing a cranial electrotherapy stimulation device designed as a non-drug medical device to relieve anxiety, insomnia, and depression using CES technology. Each kit includes 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 designated by NSN 6515-01-691-8183 and must comply with FDA Regulation 882.5800 as a Class II medical device, requiring compliance with 510(k) clearance, registration and listing, labeling standards, and GMPs. Delivery is required within 84 days from the award date, with FOB destination terms to either APO AE 09227-0000 or Kaiserslautern, Germany. Packaging must conform to commercial standards with each unit sealed in a protective container and shipped in commercial exterior containers suitable for safe carrier transit, adhering to DLA Packaging Requirements RP001 and MIL-STD-2073-1E. Marking must follow the latest edition of Medical Marking Standard No. 1, superseding MIL-STD-129, though compliance with MIL-STD-129 is still required for certain items such as those containing radioactive or hazardous materials, which must also be labeled per 29 CFR 1910.1200. The contract mandates full adherence to DLA’s Master Solicitation for Automated Simplified Acquisitions Revision 105, incorporating a suite of FAR and DFARS clauses covering cybersecurity, information safeguarding, export control, hazardous materials handling, and prohibitions on covered telecommunications equipment and communist Chinese military company items. Offerors must submit Safety Data Sheets prior to award or risk being deemed nonresponsible, and quotes must not include items produced via additive manufacturing unless explicitly authorized. The solicitation emphasizes electronic submission via DIBBS by August 17, 2026, with payment processed through WAWF and invoicing compliant with DFARS 252.232-7003. All offers must include representations regarding small business status, System for Award Management registration, and exclusion of covered telecommunications equipment. The contracting officer is Brooke Webb of DLA Troop Support Medical Supply Chain, and the