Cleared Traditional

K130017 - VALENTINE STEEL WHEELCHAIR (FDA 510(k) Clearance)

Class I Physical Medicine device.

K130017 · Valentine Intl. , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
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May 2014
Decision
511d
Days
Class 1
Risk

K130017 is an FDA 510(k) clearance for the VALENTINE STEEL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Valentine Intl. , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on May 28, 2014 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Valentine Intl. , Ltd. devices

Submission Details

510(k) Number K130017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date May 28, 2014
Days to Decision 511 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
396d slower than avg
Panel avg: 115d · This submission: 511d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 Peers - IOR Wheelchair, Mechanical

All 455
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