MEDICAL TOILET SEAT— 510(k) K852049

Name: FDA 510(k) clearance K852049
Creator: U.S. Food and Drug Administration
Published: 1985-06-24

Substantially Equivalent

Pedro Aleman

FDA 510(k) clearance K852049 for MEDICAL TOILET SEAT, Substantially Equivalent on 1985-06-24. Applicant: Pedro Aleman. Device class: 1.

Clearance details

Applicant: Pedro Aleman
Product code: Code ILS
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1985-05-08
Decision date: 1985-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D.F. Mexico, MX

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILS

view all

K842651 — COMMODE CHAIR 982001984-08-07
K830853 — LAVATORY SEAT HEIGHTENER1983-06-08
K831547 — RAISED TOILET SEATS & NAIL CLIPPERS1983-06-08
K830425 — TOILET SEAT RAISED1983-05-09
K830852 — SHOWER STOOL W/HANDLES1983-04-05

Adverse events under product code ILS

product code ILS

Death: 4
Injury: 200
Total: 204

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.