Cleared Traditional

K994107 - AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

K994107 is an FDA 510(k) clearance for AMYSYSTEMS PTS50-50 DEGREE POWER TILT S..., manufactured by Amylior, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K994107 · Amylior, Inc. · Physical Medicine device
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Jan 2000
Decision
38d
Days
Class 2
Risk

K994107 is an FDA 510(k) clearance for the AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRI.... 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 38 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

FDA 510(k) Submission Details - K994107

510(k) Number K994107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date January 13, 2000
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K994107.
JET 1 POWERED WHEELCHAIR
K001970 · Pride Mobility Products Corp. · Sep 2000
RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · Invacare Corp. · Jul 2000
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · Invacare Corp. · Dec 1999
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · Invacare Corp. · Aug 1999
THERADYNE ROVER POWERED WHEELCHAIR
K982724 · Kurt Mfg. Co. · Aug 1999