REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM— 510(k) K111636

Substantially Equivalent

Gunnell, Inc.

FDA 510(k) clearance K111636 for REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM, Substantially Equivalent on 2012-04-03. Applicant: Gunnell, Inc..

Clearance details

Applicant: Gunnell, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2011-06-13
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millington, MI, 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.