DeviceClearance

ELITE LIGHTWEIGHT WHEELCHAIR— 510(k) K974197

Substantially Equivalent

Jaken Co., Inc.

FDA 510(k) clearance K974197 for ELITE LIGHTWEIGHT WHEELCHAIR, Substantially Equivalent on 1997-12-17. Applicant: Jaken Co., Inc.. Device class: 1.

Clearance details

Applicant
Jaken Co., 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
Fullerton, CA, US
Download summary PDFView on FDA.gov ↗

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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.