DeviceClearance

WHEELCHAIR, MODELS H001A, 4422— 510(k) K000738

Substantially Equivalent

Jackson Company, LLC

FDA 510(k) clearance K000738 for WHEELCHAIR, MODELS H001A, 4422, Substantially Equivalent on 2000-05-26. Applicant: Jackson Company, LLC. Device class: 1.

Clearance details

Applicant
Jackson Company, LLC
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
Baltimore, MD, 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 →

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