DeviceClearance

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.. Device class: 1.

Clearance details

Applicant
Gunnell, Inc.
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Millington, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IOR

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K111636

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111636.

Data sourced from openFDA. This site is unofficial and independent of the FDA.