510(k) K863047— FLEXICAIR

Substantially Equivalent

Ssi Medical Services, Inc.

Clearance details

Applicant: Ssi Medical Services, Inc.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1986-08-12
Decision date: 1986-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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.