Noddle(TM)— 510(k) K162817

Substantially Equivalent

Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.

FDA 510(k) clearance K162817 for Noddle(TM), Substantially Equivalent on 2017-01-18. Applicant: Iowa Adaptive Technologies, Inc. Dba Voxello, Inc..

Clearance details

Applicant: Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 2016-10-06
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.