Oral Device OA, Oral Device S
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181396 FDA 510(k)
- FDA Product Code
- LRK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Oral Device OA and Oral Device S are classified as anti-snoring devices designed to reduce snoring by repositioning the jaw and tongue. These devices are intended for use in patients experiencing mild to moderate obstructive snoring, helping to maintain an open airway during sleep. The Oral Device OA is a prescription-only device, while the Oral Device S is available over-the-counter (OTC).
These devices are supplied as single-use or reusable oral appliances, depending on the specific model. They are intended for use in a clinical or home setting and are not classified as MRI-compatible. The devices come in various sizes to accommodate different patient anatomies, with sizing typically determined by a dental professional or through manufacturer-provided instructions. The Oral Device OA and Oral Device S hold FDA 510(k) clearance under the classification of Class II medical devices, as per regulation number 872.5570.
Frequently asked questions
What is the primary purpose of the Oral Device OA and Oral Device S?
The Oral Device OA and Oral Device S are designed to reduce snoring by repositioning the jaw and tongue, helping to maintain an open airway during sleep. They are specifically intended for patients experiencing mild to moderate obstructive snoring. The Oral Device OA requires a prescription, while the Oral Device S is available over-the-counter, making it accessible for self-treatment under guidance.
Are these devices single-use or reusable, and how should they be supplied?
The Oral Device OA and Oral Device S can be supplied as either single-use or reusable, depending on the specific model or clinical recommendation. Reusable devices are intended for long-term use with proper cleaning and maintenance, while single-use devices are designed for one-time use. The manufacturer provides instructions for cleaning and care to ensure hygiene and longevity, particularly for reusable models.
How are the devices sized, and who determines the appropriate size?
Sizing for the Oral Device OA and Oral Device S is tailored to accommodate different patient anatomies. Typically, a dental professional assesses the patient’s mouth structure and selects the appropriate size, or the manufacturer provides sizing instructions for self-fitting (e.g., Oral Device S). Multiple sizes are available to ensure a comfortable and effective fit, reducing the risk of discomfort or improper airway alignment.
Can these devices be used in an MRI setting?
No, the Oral Device OA and Oral Device S are not classified as MRI-compatible. Patients using these devices should avoid MRI scans unless specifically cleared by a radiologist or manufacturer, as the materials or structure may pose risks in a magnetic field environment.
What regulatory approvals do these devices hold, and how does that affect their use?
Both the Oral Device OA and Oral Device S hold FDA 510(k) clearance under the classification of Class II medical devices, with the regulatory number 872.5570. This clearance indicates they meet U.S. safety and effectiveness standards for anti-snoring devices. The Oral Device OA’s prescription requirement reflects its classification as a medical device requiring professional oversight, while the Oral Device S’s over-the-counter availability simplifies access for self-treatment under general guidance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oral Device OA, Oral Device S (K181396) - FDA 510 (k), Oral Device OA, Oral Device S (K181396) — FDA 510 (k) | Innolitics, Passion For Life Healthcare (Uk) Limited - FDA 510 (k) Cleared Devices, PDF PDF Page 19 of 28 Passion for Life Healt - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181396 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Passion For Life Healthcare (Uk) Limited
Sources (1)
- FDA 510(k) K181396 24 fields · synced Oct 5, 2026