Cleared Traditional

K925336 - VALU-PLUS PAD

K925336 is an FDA 510(k) clearance for VALU-PLUS PAD, manufactured by Valmed, Inc.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K925336 · Valmed, Inc. · Physical Medicine device
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Feb 1993
Decision
113d
Days
Class 1
Risk

K925336 is an FDA 510(k) clearance for the VALU-PLUS PAD. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Valmed, Inc. (New Orleans, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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 Valmed, Inc. devices

FDA 510(k) Submission Details - K925336

510(k) Number K925336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date February 12, 1993
Days to Decision 113 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 12
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K925336.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
WHEELCHAIR ACCESSORIES
K840629 · Poirier S.A. · Feb 1984