POWERED WHEELCHAIR— 510(k) K962565

Name: FDA 510(k) clearance K962565
Creator: U.S. Food and Drug Administration
Published: 1997-03-20

Substantially Equivalent

Orthofab, Inc.

FDA 510(k) clearance K962565 for POWERED WHEELCHAIR, Substantially Equivalent on 1997-03-20. Applicant: Orthofab, Inc.. Device class: 2.

Clearance details

Applicant: Orthofab, Inc.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 1996-07-01
Decision date: 1997-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, Quebec, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Orthofab, Inc.

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K952675 — ORTHOFAB WHEELCHAIR1996-05-07
K950903 — ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)1995-04-05
K950904 — ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)1995-04-05
K884812 — KARMA-RS, KARMA-FS WHEELCHAIRS1988-12-27
K860095 — DIGIKIT NONPNEUMATIC TOURNIQUET1986-01-24

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.