POWER DRIVE CHAIR, MODEL: TMM6— 510(k) K091043

Name: FDA 510(k) clearance K091043
Creator: U.S. Food and Drug Administration
Published: 2009-05-11

Substantially Equivalent

Transmotion Medical, Inc.

FDA 510(k) clearance K091043 for POWER DRIVE CHAIR, MODEL: TMM6, Substantially Equivalent on 2009-05-11. Applicant: Transmotion Medical, Inc.. Device class: 2.

Clearance details

Applicant: Transmotion Medical, Inc.
Product code: Code INK
Device class: Class 2
Regulation: 21 CFR 890.3690
Advisory panel: Physical Medicine
Date received: 2009-04-13
Decision date: 2009-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code INK

product code INK

Malfunction: 708
Other: 1
Total: 709

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.