Cleared Traditional

K872934 - STAND AID

K872934 is an FDA 510(k) clearance for STAND AID, manufactured by Stand Aid of Iowa, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K872934 · Stand Aid of Iowa, Inc. · Physical Medicine device
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Nov 1987
Decision
119d
Days
Class 2
Risk

K872934 is an FDA 510(k) clearance for the STAND AID. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Stand Aid of Iowa, Inc. (Sheldon, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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.

FDA 510(k) Submission Details - K872934

510(k) Number K872934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date November 23, 1987
Days to Decision 119 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
3d slower than avg
Panel avg: 116d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPL Wheelchair, Standup

All 65
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K872934.
STANDING DANI WHEELSTAND
K890602 · Davis Positioning Systems, Inc. · Mar 1989
B.A.C. 1000 MOBILE STANDING DEVICE
K884840 · Luconex, Inc. · Mar 1989
PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR
K884541 · Pro-Vertic, Inc. · Nov 1988
I.D.C. STANDUP WHEELCHAIRS
K863118 · Intl. Diffusion Consommateur · Aug 1986
ARISE, VIVRE DEBOUT
K862305 · Natco Corp. · Jul 1986
STANDING WHEELER
K862013 · Engineering Mechanics, Co. · Jul 1986
K872934 · STAND AID
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