PRIMECHAIR— 510(k) K021199

Substantially Equivalent

Dalton Medical Corp.

FDA 510(k) clearance K021199 for PRIMECHAIR, Substantially Equivalent on 2002-07-12. Applicant: Dalton Medical Corp..

Clearance details

Applicant: Dalton Medical Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2002-04-16
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

Download summary PDF View on FDA.gov ↗

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.