TOTAL CONTACT SEAT RIPPLE SYSTEM— 510(k) K943433

Name: FDA 510(k) clearance K943433
Creator: U.S. Food and Drug Administration
Published: 1995-07-31

Substantially Equivalent

Numotech, Inc.

FDA 510(k) clearance K943433 for TOTAL CONTACT SEAT RIPPLE SYSTEM, Substantially Equivalent on 1995-07-31. Applicant: Numotech, Inc.. Device class: 2.

Clearance details

Applicant: Numotech, Inc.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1994-07-15
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sun Valley, CA, 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.