Cleared Traditional

RGK Daily Range Wheelchairs (K200135) - FDA 510(k) Clearance

Class I Physical Medicine device.

K200135 · Rgk Wheelchairs, Ltd. · Physical Medicine device
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Sep 2020
Decision
233d
Days
Class 1
Risk

K200135 is an FDA 510(k) clearance for the RGK Daily Range Wheelchairs. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rgk Wheelchairs, Ltd. (Burntwood, GB). The FDA issued a Cleared decision on September 10, 2020 after a review of 233 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Rgk Wheelchairs, Ltd. devices

Submission Details

510(k) Number K200135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2020
Decision Date September 10, 2020
Days to Decision 233 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
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 456
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K200135.
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