Cleared Traditional

K981486 - STAIR-LIFT

K981486 is an FDA 510(k) clearance for STAIR-LIFT, manufactured by Garaventa (Canada) , Ltd.. The device is a Class 2 Physical Medicine device with product code ING cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K981486 · Garaventa (Canada) , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
68d
Days
Class 2
Risk

K981486 is an FDA 510(k) clearance for the STAIR-LIFT. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Garaventa (Canada) , Ltd. (Washington, US). The FDA issued a Cleared decision on July 1, 1998 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3930 - 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.

View all Garaventa (Canada) , Ltd. devices

FDA 510(k) Submission Details - K981486

510(k) Number K981486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1998
Decision Date July 01, 1998
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ING Device Classification - Class 2, Special Controls

Product Code ING Elevator, Wheelchair, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3930
Definition A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For 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.