RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO— 510(k) K001079

Name: FDA 510(k) clearance K001079
Creator: U.S. Food and Drug Administration
Published: 2000-05-01

Substantially Equivalent

Arjo, Inc.

FDA 510(k) clearance K001079 for RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO, Substantially Equivalent on 2000-05-01. Applicant: Arjo, Inc.. Device class: 2.

Clearance details

Applicant: Arjo, Inc.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 2000-04-04
Decision date: 2000-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILJ

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K082951 — IMMERSION HYDROBATH2009-04-08
K052479 — MBATH 1000 (60)2006-01-26
K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM2004-04-05
K012057 — CASCADE BATH, MODEL 69002001-07-19

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.