PREMIER 2 WHEELCHAIR— 510(k) K930412

Name: FDA 510(k) clearance K930412
Creator: U.S. Food and Drug Administration
Published: 1993-03-31

Substantially Equivalent

Everest & Jennings, Inc.

FDA 510(k) clearance K930412 for PREMIER 2 WHEELCHAIR, Substantially Equivalent on 1993-03-31. Applicant: Everest & Jennings, Inc.. Device class: 1.

Clearance details

Applicant: Everest & Jennings, Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1993-01-26
Decision date: 1993-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Earth City, MO, US

Download summary PDF View on FDA.gov ↗

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K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

More clearances from Everest & Jennings, Inc.

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K925865 — KID POWER1994-03-28
K940303 — RECORD1994-02-17
K940304 — NITRO1994-02-17
K930411 — UNIVERSAL WHEELCHAIR1993-03-31
K930413 — PREMIER CLASSIC1993-03-31

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.