Cleared Traditional

K090856 - JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)

K090856 is an FDA 510(k) clearance for JOURNEY (OR RPSP), manufactured by Thyssenkrupp Ceteco Srl. The device is a Class 2 Physical Medicine device with product code ING cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K090856 · Thyssenkrupp Ceteco Srl · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
58d
Days
Class 2
Risk

K090856 is an FDA 510(k) clearance for the JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02). Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Thyssenkrupp Ceteco Srl (Pisa, IT). The FDA issued a Cleared decision on May 27, 2009 after a review of 58 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.

FDA 510(k) Submission Details - K090856

510(k) Number K090856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date May 27, 2009
Days to Decision 58 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
58d faster than avg
Panel avg: 116d · This submission: 58d
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 28
Devices cleared under the same product code (ING) and FDA review panel - the closest regulatory comparables to K090856.
LIFTKAR PT
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K061514 · Bruno Independent Living Aids, Inc. · Jul 2006
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K033469 · Garaventa Accessibility · Jan 2004
K090856 · JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
Download PDF FDA Summary Thyssenkrupp Ceteco S…