FORTRESS 1000FS ADD-ON POWER UNIT— 510(k) K895596

Substantially Equivalent

Fortress Scientific , Ltd.

FDA 510(k) clearance K895596 for FORTRESS 1000FS ADD-ON POWER UNIT, Substantially Equivalent on 1989-10-23. Applicant: Fortress Scientific , Ltd..

Clearance details

Applicant: Fortress Scientific , Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1989-09-15
Decision date: 1989-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.