Hushd Pro Avera
510(k) K232025
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232025 | Date9 May 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LRK
- FDA applicant
- Good Sleep CO Pte , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5570
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hushd Pro Avera is an oral appliance classified as an Anti-Snoring Device, designed to reduce or alleviate snoring in adults. It is intended for use in patients who are CPAP intolerant or seeking an alternative treatment for mild to moderate obstructive sleep apnea. Constructed from medical-grade nylon, this device is custom-fitted to the patient’s dentition to maintain proper positioning during use.
Supplied as a single-use or reusable device (depending on clinical guidance), the Hushd Pro Avera requires a fixed upper denture for secure placement. It is not MRI-safe and must be stored in a clean, dry environment as directed by the manufacturer. Authorized under FDA 510(k) clearance (K232025) as Substantially Equivalent, it adheres to regulatory standards for dental anti-snoring devices under classification 2 (872.5570).
Other devices from Good Sleep CO Pte, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Hushd Pro Avera designed to treat?
The Hushd Pro Avera is an oral appliance classified as an Anti-Snoring Device, specifically designed to reduce or alleviate snoring in adults. It is also intended for patients who are CPAP intolerant or seeking an alternative treatment for mild to moderate obstructive sleep apnea. The device works by maintaining proper positioning of the jaw and tongue to keep airways open during sleep.
How is the Hushd Pro Avera supplied, and what does this mean for its use?
The Hushd Pro Avera can be supplied as either a single-use or reusable device, depending on clinical guidance. If reusable, it must be cleaned and stored properly between uses to maintain hygiene and functionality. The device requires a fixed upper denture for secure placement, ensuring it remains effective during use.
Is the Hushd Pro Avera safe for MRI scans?
No, the Hushd Pro Avera is not MRI-safe. Patients should remove the device before undergoing an MRI scan to avoid potential risks associated with magnetic fields. Always follow manufacturer instructions and consult with a healthcare provider if unsure.
What materials is the Hushd Pro Avera made from, and why does this matter?
The Hushd Pro Avera is constructed from medical-grade nylon, a durable and biocompatible material suitable for oral use. This ensures the device is safe for prolonged contact with the mouth while maintaining its structural integrity and hygiene standards.
How should the Hushd Pro Avera be stored?
The device must be stored in a clean, dry environment as directed by the manufacturer. Proper storage prevents contamination, moisture damage, and degradation of the material, ensuring the device remains effective and safe for use. Always follow the manufacturer’s guidelines for maintenance.