Cleared Traditional

K941642 - ASCENDA

K941642 is an FDA 510(k) clearance for ASCENDA, manufactured by American Stair-Glide Corp.. The device is a Class 2 Physical Medicine device with product code ING cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K941642 · American Stair-Glide Corp. · Physical Medicine device
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Jun 1994
Decision
70d
Days
Class 2
Risk

K941642 is an FDA 510(k) clearance for the ASCENDA. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by American Stair-Glide Corp. (Grandview, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 70 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 American Stair-Glide Corp. devices

FDA 510(k) Submission Details - K941642

510(k) Number K941642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date June 13, 1994
Days to Decision 70 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
46d faster than avg
Panel avg: 116d · This submission: 70d
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.

Regulatory Peers - ING Elevator, Wheelchair, Portable

All 17
Devices cleared under the same product code (ING) and FDA review panel - the closest regulatory comparables to K941642.
TRUSLIFT PORCH LIFT
K964134 · Trus T Lift · Dec 1996
WHEELCHAIR ELEVATOR
K960276 · Services Industriels Savaria, Inc. · Apr 1996
V-1504 VERTICAL PLATFORM LIFT
K960739 · Barnes,Richardson & Colburn · Apr 1996
ULTRAGATER WHEELCHAIR LIFT
K922624 · Crow River Industries, Inc. · Jul 1992
MOBILIZATION & TRACTION TABLE
K844359 · Chattanooga Group, Inc. · Feb 1985