510(k) K902206— CONTROL 1 ENVIRONMENTAL CONTROL

Substantially Equivalent

Prentke Romich Co.

Clearance details

Applicant: Prentke Romich Co.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1990-05-16
Decision date: 1990-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wooster, OH, US

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.