AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS— 510(k) K882229

Name: FDA 510(k) clearance K882229
Creator: U.S. Food and Drug Administration
Published: 1988-08-16

Substantially Equivalent

Biologics Intl., Inc.

FDA 510(k) clearance K882229 for AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS, Substantially Equivalent on 1988-08-16. Applicant: Biologics Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biologics Intl., Inc.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1988-05-20
Decision date: 1988-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Rocks Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.