Cleared Traditional

K042535 - ADVENTURE A10

K042535 is an FDA 510(k) clearance for ADVENTURE A10, manufactured by Ulrich Alber GmbH. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K042535 · Ulrich Alber GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
15d
Days
Class 2
Risk

K042535 is an FDA 510(k) clearance for the ADVENTURE A10. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Ulrich Alber GmbH (Albstadt-Tailfingen, DE). The FDA issued a Cleared decision on October 5, 2004 after a review of 15 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 Ulrich Alber GmbH devices

FDA 510(k) Submission Details - K042535

510(k) Number K042535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date October 05, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 340
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K042535.
HOVEROUND E100 POWER CHAIR
K043069 · Hoveround Corp. · Dec 2004
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K042545 · Hoveround Corp. · Oct 2004
JAZZY 600
K042612 · Pride Mobility Products Corp. · Oct 2004
POWERED WHEELCHAIR, MODEL B-500
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POWERED WHEELCHAIR, MODEL B-600
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POWERED WHEELCHAIR, MODEL C-1000
K041211 · Otto Bock Healthcare LP · Oct 2004