Cleared Traditional

K811482 - INCONTINENT PAD (FDA 510(k) Clearance)

Class I Physical Medicine device.

K811482 · Fred Sammons, Inc. · Physical Medicine device
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Aug 1981
Decision
91d
Days
Class 1
Risk

K811482 is an FDA 510(k) clearance for the INCONTINENT PAD. Classified as Accessories, Wheelchair (product code KNO), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3910 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fred Sammons, Inc. devices

Submission Details

510(k) Number K811482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date August 25, 1981
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNO Accessories, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.