Cleared Traditional

K811482 - INCONTINENT PAD

K811482 is an FDA 510(k) clearance for INCONTINENT PAD, manufactured by Fred Sammons, Inc.. The device is a Class 1 Physical Medicine device with product code KNO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K811482 · Fred Sammons, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K811482

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KNO Device Classification - Class 1, General Controls

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.

Regulatory Peers - KNO Accessories, Wheelchair

All 30
Devices cleared under the same product code (KNO) and FDA review panel - the closest regulatory comparables to K811482.
WHEEL CHAIR ACCESSORIES
K821642 · Fred Sammons, Inc. · Jun 1982
BK-6453 RIMMED ACRYLIC LAP TRAY KIT
K813627 · Fred Sammons, Inc. · Jan 1982
WHEELCHAIR ACCESSORIES
K812350 · Fred Sammons, Inc. · Sep 1981
WHEELCHAIR RAMPS
K811486 · Fred Sammons, Inc. · Jun 1981
WHEELCHAIR ACCESSORIES
K811491 · Fred Sammons, Inc. · Jun 1981
BODY STRAP
K810439 · Fred Sammons, Inc. · Mar 1981