OVERLANDER PEV 2000— 510(k) K983497

Substantially Equivalent

Raye'S, Inc.

FDA 510(k) clearance K983497 for OVERLANDER PEV 2000, Substantially Equivalent on 1999-06-27. Applicant: Raye'S, Inc..

Clearance details

Applicant: Raye'S, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1998-10-05
Decision date: 1999-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellis, KS, 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.