Cleared Traditional

K200135 - RGK Daily Range Wheelchairs

K200135 is an FDA 510(k) clearance for RGK Daily Range Wheelchairs, manufactured by Rgk Wheelchairs, Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 233-day FDA review.

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

FDA 510(k) Submission Details - K200135

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.

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 Peers - IOR Wheelchair, Mechanical

All 235
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