RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT— 510(k) K940851

Substantially Equivalent for Some Indications

Redman, Inc.

FDA 510(k) clearance K940851 for RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT, Substantially Equivalent for Some Indications on 1995-02-03. Applicant: Redman, Inc..

Clearance details

Applicant: Redman, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1994-02-23
Decision date: 1995-02-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Tucson, AZ, US

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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, 2020-01-01 through 2026-04-23. 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.