DeviceClearance

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM— 510(k) K040772

Substantially Equivalent

Penner Manufacturing, Inc.

FDA 510(k) clearance K040772 for PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM, Substantially Equivalent on 2004-04-05. Applicant: Penner Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant
Penner Manufacturing, Inc.
Product code
Code ILJ
Device class
Class 2
Regulation
21 CFR 890.5100
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ohaha, NE, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ILJ

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Adverse events under product code ILJ

product code ILJ
Death
4
Total
4

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K040772

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040772.

Data sourced from openFDA. This site is unofficial and independent of the FDA.