Cleared Traditional

K973473 - ASLI

K973473 is an FDA 510(k) clearance for ASLI, manufactured by Texin Industrial (International) , Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K973473 · Texin Industrial (International) , Ltd. · Physical Medicine device
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Sep 1997
Decision
11d
Days
Class 1
Risk

K973473 is an FDA 510(k) clearance for the ASLI. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Texin Industrial (International) , Ltd. (Vancouver, Bc, CA). The FDA issued a Cleared decision on September 26, 1997 after a review of 11 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.

View all Texin Industrial (International) , Ltd. devices

FDA 510(k) Submission Details - K973473

510(k) Number K973473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1997
Decision Date September 26, 1997
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
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

Tuv Product Service, Inc.
CAROLE STAMP

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 125
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K973473.
MECHANICAL FOLDING WHEEL CHAIR
K973491 · Heartway Medical Products Co., Ltd. · Dec 1997
QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES
K973673 · Sunrise Medical, Inc. · Nov 1997
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
K973418 · Assembly Required Dist., Inc. · Oct 1997
TOOL-LESS WHEEL CHAIR
K972797 · Sunrise Medical, Inc. · Aug 1997
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
K971389 · Pdg Product Design Group, Inc. · May 1997
ADVENTURER
K971142 · T.E.S., Ltd. · Apr 1997

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.