HYGIENE ADAPTORS— 510(k) K821638

Name: FDA 510(k) clearance K821638
Creator: U.S. Food and Drug Administration
Published: 1982-06-11

Substantially Equivalent

Fred Sammons, Inc.

FDA 510(k) clearance K821638 for HYGIENE ADAPTORS, Substantially Equivalent on 1982-06-11. Applicant: Fred Sammons, Inc.. Device class: 1.

Clearance details

Applicant: Fred Sammons, Inc.
Product code: Code ILS
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1982-06-03
Decision date: 1982-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILS

view all

K852049 — MEDICAL TOILET SEAT1985-06-24
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

More clearances from Fred Sammons, Inc.

view all

K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)1988-05-06
K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)1988-04-01
K831549 — ARM SLINGS1983-06-30
K831548 — SPLINTS1983-06-27
K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE1983-06-24

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.