Cleared Traditional

K024345 - B.07 STAIRWAY CHAIRLIFT

K024345 is an FDA 510(k) clearance for B.07 STAIRWAY CHAIRLIFT, manufactured by Services Industriels Savaria, Inc.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K024345 · Services Industriels Savaria, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
61d
Days
Class 2
Risk

K024345 is an FDA 510(k) clearance for the B.07 STAIRWAY CHAIRLIFT. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Services Industriels Savaria, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 61 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K024345

510(k) Number K024345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2002
Decision Date February 26, 2003
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 116d · This submission: 61d
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 32
Devices cleared under the same product code (ILK) and FDA review panel - the closest regulatory comparables to K024345.
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K033438 · Bruno Independent Living Aids, Inc. · Nov 2003
SUMMIT STAIRWAY LIFT
K032880 · Summit Lifts, Inc. · Nov 2003
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT
K023852 · Services Industriels Savaria, Inc. · Mar 2003
STEP-SAVER STAIRWAY CHAIRLIFT
K024167 · Services Industriels Savaria, Inc. · Feb 2003
BRUNO ELECTRA-RIDE, MODEL SRE-2700
K022509 · Bruno Independent Living Aids, Inc. · Aug 2002
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
K970927 · Bruno Independent Living Aids, Inc. · Aug 1997
K024345 · B.07 STAIRWAY CHAIRLIFT
Download PDF FDA Summary Services Industriels …