Cleared Traditional

K061475 - ASTROTILT MANUAL WHEELCHAIR

K061475 is an FDA 510(k) clearance for ASTROTILT MANUAL WHEELCHAIR, manufactured by Pdg Product Design Group, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061475 · Pdg Product Design Group, Inc. · Physical Medicine device
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Jun 2006
Decision
15d
Days
Class 1
Risk

K061475 is an FDA 510(k) clearance for the ASTROTILT MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pdg Product Design Group, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on June 14, 2006 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 890.3850 - 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 - K061475

510(k) Number K061475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date June 14, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
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. Third-party reviewed.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Underwriters Laboratories, Inc.
MARC MOUSER

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 - IOR Wheelchair, Mechanical

All 423
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K061475.
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
K062218 · Jan Mao Industries Co., Ltd. · Aug 2006
COUGAR WHEELCHAIR
K061810 · R82 A/S · Aug 2006
MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S
K061694 · Medcare Manufacturing, Inc. · Jul 2006
FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR
K061010 · Future Mobility Healthcare, Inc. · May 2006
7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
K061273 · Nova Ortho-Med, Inc. · May 2006
TRIPOD
K060926 · Freedom Designs, Inc. · May 2006

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.

K061475 · ASTROTILT MANUAL WHEELCHAIR
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