DeviceClearance

THE NIMBLE ROCKET POWERED WHEELCHAIR— 510(k) K010941

Substantially Equivalent

Nimble, Inc.

FDA 510(k) clearance K010941 for THE NIMBLE ROCKET POWERED WHEELCHAIR, Substantially Equivalent on 2001-06-22. Applicant: Nimble, Inc.. Device class: 2.

Clearance details

Applicant
Nimble, Inc.
Product code
Code ITI
Device class
Class 2
Regulation
21 CFR 890.3860
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ITI

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Adverse events under product code ITI

product code ITI
Death
34
Injury
778
Malfunction
1,085
Other
1
Total
1,898

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.