TC SERIES (TILT RECLINER)— 510(k) K981419

Name: FDA 510(k) clearance K981419
Creator: U.S. Food and Drug Administration
Published: 1998-06-10

Substantially Equivalent

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

FDA 510(k) clearance K981419 for TC SERIES (TILT RECLINER), Substantially Equivalent on 1998-06-10. Applicant: Get A Life-Give A Living Plus Kids Project, Inc.. Device class: 1.

Clearance details

Applicant: Get A Life-Give A Living Plus Kids Project, Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1998-04-20
Decision date: 1998-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sr. Petersburg, FL, US

Download summary PDF View on FDA.gov ↗

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

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K981418 — TC SERIES (TRANSPORT)1998-06-10
K981420 — TC SERIES (WIDE)1998-06-10
K981421 — TC SERIES (RECLINER)1998-06-10
K981422 — TC SERIES1998-06-10

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.