{"product_id":"cwtul-anti-snore-device-28-fda-cleared-mandibular-advancement-for-adults","title":"CWTUL Anti-Snore Device-28 — FDA-Cleared Mandibular Advancement for Adults","description":"\u003ch2\u003eOverview\u003c\/h2\u003e\u003cp\u003eThe CWTUL Anti-Snore Device-28 is a non-pharmacological option designed for adults 18 and older. This FDA-cleared Class II medical device (K200657) aims to reduce snoring by gently guiding the lower jaw forward to support airflow during sleep. Built to align with recognized safety and quality standards, it presents a practical at-home solution without the need for prescriptions.\u003c\/p\u003e\u003ch2\u003eHow it works\u003c\/h2\u003e\u003cp\u003eMandibular advancement shifts the lower jaw forward to help open the airway, potentially promoting smoother breathing through the night. The device is crafted from biocompatible materials and designed to be comfortable for extended wear while you sleep. The approach mirrors clinically validated concepts while remaining designed for personal use in the home setting.\u003c\/p\u003e\u003ch3\u003eWhat you may notice\u003c\/h3\u003e\u003cp\u003eResults depend on individual fit and adaptation. Many users find a change in nighttime breathing patterns as they become accustomed to the device, with airflow dynamics adjusting gradually as the jaw position is customized. The goal is to support a consistent breathing rhythm during sleep.\u003c\/p\u003e\u003ch3\u003eComfort, customization, and fit\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eCustomizable and comfortable fit via boil-and-bite upper\/lower trays with polycarbonate shells and EVA lining.\u003c\/li\u003e\n\u003cli\u003eSix adjustable advancement bars offer 1 mm increments, up to 6 mm of protrusion for personalized comfort.\u003c\/li\u003e\n\u003cli\u003eDesigned to be reusable and easy to clean, supporting routine at-home care.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eClinical validation and safety\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eSubstantially equivalent to predicate devices with identical ISO 10993-1 biocompatible materials, ensuring non-toxic, non-irritating contact with mucosal tissue.\u003c\/li\u003e\n\u003cli\u003eFDA-cleared and aligned with 21 CFR 872.5570—emphasizing a safety-first design for at-home use.\u003c\/li\u003e\n\u003cli\u003eRigorous testing for tensile\/flexural strength and water absorption under standardized conditions to support long-term use.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eUsage and maintenance\u003c\/h3\u003e\u003cp\u003eDesigned for home use, the device is reusable and straightforward to clean. Rinsing daily with toothpaste or effervescent tablets is recommended, and the product has passed human factors testing for intuitive at-home customization (ISO 14971).\u003c\/p\u003e\u003ch3\u003eWhat’s included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBoil-and-bite thermoplastic trays (upper and lower)\u003c\/li\u003e\n\u003cli\u003ePolycarbonate shells with EVA lining\u003c\/li\u003e\n\u003cli\u003e6 adjustable advancement bars (1 mm increments, up to 6 mm)\u003c\/li\u003e\n\u003cli\u003eClear guidance for setup and daily care\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eNote: This description highlights features and intended use without guaranteeing results. Individual experience may vary based on fit, adaptation period, and sleep environment.\u003c\/p\u003e\n\u003csection class=\"product-faq-snippet\"\u003e\u003ch3\u003eFAQ\u003c\/h3\u003e\n\u003cdiv class=\"faq-item\"\u003e\n\u003cp class=\"faq-q\"\u003eQ: What is the Anti-Snore Device-28 and who can use it?\u003c\/p\u003e\n\u003cp class=\"faq-a\"\u003eA: FDA-cleared Class II medical device for adults 18+, designed to reduce snoring by advancing the lower jaw to improve airflow.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"faq-item\"\u003e\n\u003cp class=\"faq-q\"\u003eQ: How easy is it to use and maintain?\u003c\/p\u003e\n\u003cp class=\"faq-a\"\u003eA: Reusable with boil-and-bite trays, six adjustable bars, and simple daily cleaning using toothpaste or effervescent tablets.\u003c\/p\u003e\n\u003c\/div\u003e\u003c\/section\u003e","brand":"CWTUL","offers":[{"title":"Default Title","offer_id":43878210928728,"sku":"B0FGKQNHZ3","price":51.45,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/2454\/1784\/files\/cwtul-anti-snore-device-28-front-view.jpg?v=1773647825","url":"https:\/\/elovita.co.uk\/products\/cwtul-anti-snore-device-28-fda-cleared-mandibular-advancement-for-adults","provider":" Elovita | Premium Vitamins, Advanced Supplements \u0026 Melatonin in the UK","version":"1.0","type":"link"}