Cleared Traditional

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM (K994072) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994072 · Amylior, Inc. · Physical Medicine device
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Jan 2000
Decision
42d
Days
Class 2
Risk

K994072 is an FDA 510(k) clearance for the AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Amylior, Inc. (Note-Dame Of Ile Perrot,Quebec, CA). The FDA issued a Cleared decision on January 13, 2000 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Amylior, Inc. devices

Submission Details

510(k) Number K994072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date January 13, 2000
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 577
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K994072.
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