UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)— 510(k) K973418

Name: FDA 510(k) clearance K973418
Creator: U.S. Food and Drug Administration
Published: 1997-10-09

Substantially Equivalent

Assembly Required Dist., Inc.

FDA 510(k) clearance K973418 for UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4), Substantially Equivalent on 1997-10-09. Applicant: Assembly Required Dist., Inc.. Device class: 1.

Clearance details

Applicant: Assembly Required Dist., Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1997-09-10
Decision date: 1997-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commack, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.