TUBMATE— 510(k) K811301

Substantially Equivalent

American Stair-Glide Corp.

FDA 510(k) clearance K811301 for TUBMATE, Substantially Equivalent on 1981-05-27. Applicant: American Stair-Glide Corp..

Clearance details

Applicant: American Stair-Glide Corp.
Product code: Code ILS
Advisory panel: Physical Medicine
Date received: 1981-05-11
Decision date: 1981-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILS

product code ILS

Death: 4
Injury: 200
Total: 204

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.