SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE— 510(k) K962327

Substantially Equivalent

Sekure Seat Corp.

FDA 510(k) clearance K962327 for SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE, Substantially Equivalent on 1997-03-06. Applicant: Sekure Seat Corp..

Clearance details

Applicant: Sekure Seat Corp.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-06-17
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hickory, NC, US

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.