SAFETY PLUS MODEL 501— 510(k) K881051

Substantially Equivalent

Safety Rehab Systems, Inc.

FDA 510(k) clearance K881051 for SAFETY PLUS MODEL 501, Substantially Equivalent on 1988-03-21. Applicant: Safety Rehab Systems, Inc..

Clearance details

Applicant: Safety Rehab Systems, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1988-03-11
Decision date: 1988-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.