ZQuiet Advance— 510(k) K213088

Substantially Equivalent

Sleeping Well, LLC

FDA 510(k) clearance K213088 for ZQuiet Advance, Substantially Equivalent on 2022-06-15. Applicant: Sleeping Well, LLC.

Clearance details

Applicant: Sleeping Well, LLC
Product code: Code LRK
Advisory panel: Dental
Date received: 2021-09-24
Decision date: 2022-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelburne, VT, US

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.