ZQuiet— 510(k) K180124

Substantially Equivalent

Sleeping Well, LLC

FDA 510(k) clearance K180124 for ZQuiet, Substantially Equivalent on 2018-06-12. Applicant: Sleeping Well, LLC.

Clearance details

Applicant: Sleeping Well, LLC
Product code: Code LRK
Advisory panel: Dental
Date received: 2018-01-16
Decision date: 2018-06-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.