Cleared Traditional

K151492 - Kudu (FDA 510(k) Clearance)

Class I Physical Medicine device.

K151492 · R82 A/S · Physical Medicine device
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May 2016
Decision
352d
Days
Class 1
Risk

K151492 is an FDA 510(k) clearance for the Kudu. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by R82 A/S (Gedved, DK). The FDA issued a Cleared decision on May 20, 2016 after a review of 352 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all R82 A/S devices

Submission Details

510(k) Number K151492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2015
Decision Date May 20, 2016
Days to Decision 352 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 115d · This submission: 352d
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 453
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K151492.
Manual Wheelchair (7101L, 7102LHD)
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Manual Wheelchair (W45)
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Manual Wheelchair (W47)
K252828 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Dec 2025
Manual Wheelchair (HM305-Air1, HM305-Air2)
K252687 · Suzhou Master Machinery Manufacturing Co.,Ltd · Nov 2025