POWER WHEELCHAIR CONVERSION KIT— 510(k) K943789

Substantially Equivalent for Some Indications

Alber Technologies, Inc.

FDA 510(k) clearance K943789 for POWER WHEELCHAIR CONVERSION KIT, Substantially Equivalent for Some Indications on 1994-11-08. Applicant: Alber Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Alber Technologies, 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 for Some Indications
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

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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.