TC SERIES— 510(k) K981422

Substantially Equivalent

Get A Life-Give A Living Plus Kids Project, Inc.

FDA 510(k) clearance K981422 for TC SERIES, Substantially Equivalent on 1998-06-10. Applicant: Get A Life-Give A Living Plus Kids Project, Inc..

Clearance details

Applicant: Get A Life-Give A Living Plus Kids Project, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-04-20
Decision date: 1998-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinellas Park, FL, US

Download summary PDF View on FDA.gov ↗

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.