M100 POWERED WHEELCHAIR— 510(k) K925724

Substantially Equivalent for Some Indications

Mcnally Industries, Inc.

FDA 510(k) clearance K925724 for M100 POWERED WHEELCHAIR, Substantially Equivalent for Some Indications on 1994-03-29. Applicant: Mcnally Industries, Inc..

Clearance details

Applicant: Mcnally Industries, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1992-11-13
Decision date: 1994-03-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Grantsburg, WI, US

Download summary PDF View on FDA.gov ↗

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.