Cleared Traditional

K932625 - STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT

K932625 is an FDA 510(k) clearance for STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT, manufactured by Stair Assist Corp.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K932625 · Stair Assist Corp. · Physical Medicine device
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Sep 1993
Decision
121d
Days
Class 2
Risk

K932625 is an FDA 510(k) clearance for the STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Stair Assist Corp. (Portland, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5150 - 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 Stair Assist Corp. devices

FDA 510(k) Submission Details - K932625

510(k) Number K932625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1993
Decision Date September 30, 1993
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILK Device Classification - Class 2, Special Controls

Product Code ILK Transport, Patient, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5150
Definition A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs.
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 - ILK Transport, Patient, Powered

All 11
Devices cleared under the same product code (ILK) and FDA review panel - the closest regulatory comparables to K932625.
HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
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BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
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STAIR VEYOR
K882091 · Pride Health Care, Inc. · May 1988