MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE— 510(k) K875321

Name: FDA 510(k) clearance K875321
Creator: U.S. Food and Drug Administration
Published: 1988-01-27

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K875321 for MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE, Substantially Equivalent on 1988-01-27. Applicant: Kinetic Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1987-12-29
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.