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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · 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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITI Wheelchair, Powered

All 592
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K042535.
GENEMAX POWER WHEELCHAIR, PW4
K042749 · Genemax Medical Products Industry Corp. · Nov 2004
HOVEROUND MPV-5 POWERCHAIR
K042545 · Hoveround Corp. · Oct 2004
JAZZY 600
K042612 · Pride Mobility Products Corp. · Oct 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · Otto Bock Healthcare LP · Oct 2004
POWERED WHEELCHAIR, MODEL B-600
K041210 · Otto Bock Healthcare LP · Oct 2004
POWERED WHEELCHAIR, MODEL C-1000
K041211 · Otto Bock Healthcare LP · Oct 2004

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K042535 · ADVENTURE A10
Download PDF FDA Summary Ulrich Alber GmbH