WIN-2 TANGO ELITE NP— 510(k) K013361

Substantially Equivalent

Durable Medical Equipment, Inc.

FDA 510(k) clearance K013361 for WIN-2 TANGO ELITE NP, Substantially Equivalent on 2002-02-26. Applicant: Durable Medical Equipment, Inc..

Clearance details

Applicant: Durable Medical Equipment, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2001-10-10
Decision date: 2002-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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.