Tenex Health TX System— 510(k) K153299

Substantially Equivalent

Tenex Health, Inc.

FDA 510(k) clearance K153299 for Tenex Health TX System, Substantially Equivalent on 2016-03-03. Applicant: Tenex Health, Inc..

Clearance details

Applicant: Tenex Health, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2015-11-13
Decision date: 2016-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest,, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.