Hushd Avera— 510(k) K252161

Substantially Equivalent

Good Sleep CO Pte , Ltd.

FDA 510(k) clearance K252161 for Hushd Avera, Substantially Equivalent on 2025-11-25. Applicant: Good Sleep CO Pte , Ltd..

Clearance details

Applicant: Good Sleep CO Pte , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2025-07-10
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.