CRS ULTRALITE PREMIER— 510(k) K851257

Name: FDA 510(k) clearance K851257
Creator: U.S. Food and Drug Administration
Published: 1985-06-28

Substantially Equivalent

Everest & Jennings, Inc.

FDA 510(k) clearance K851257 for CRS ULTRALITE PREMIER, Substantially Equivalent on 1985-06-28. 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: 1985-03-28
Decision date: 1985-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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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
K930412 — PREMIER 2 WHEELCHAIR1993-03-31

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.