DALTON FOLDING WHEELCHAIRS— 510(k) K850178

Name: FDA 510(k) clearance K850178
Creator: U.S. Food and Drug Administration
Published: 1985-04-25

Substantially Equivalent

Dalton Instrument Corp.

FDA 510(k) clearance K850178 for DALTON FOLDING WHEELCHAIRS, Substantially Equivalent on 1985-04-25. Applicant: Dalton Instrument Corp.. Device class: 1.

Clearance details

Applicant: Dalton Instrument Corp.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1985-01-17
Decision date: 1985-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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K101719 — TACAMO MANUAL WHEELCHAIR2010-08-25
K904843 — OSCAR(TM) II CAPNOMETER & PULSE OXIMETER1991-04-09

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.