Cleared Traditional

K130982 - LERADO, POWER WHEELCHAIR

K130982 is an FDA 510(k) clearance for LERADO, manufactured by Lerado Global (Macao Commercial Offshore) Limited. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K130982 · Lerado Global (Macao Commercial Offshore) Limited · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
325d
Days
Class 2
Risk

K130982 is an FDA 510(k) clearance for the LERADO, POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Lerado Global (Macao Commercial Offshore) Limited (Macau, CN). The FDA issued a Cleared decision on February 28, 2014 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Lerado Global (Macao Commercial Offshore) Limited devices

FDA 510(k) Submission Details - K130982

510(k) Number K130982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2013
Decision Date February 28, 2014
Days to Decision 325 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
210d slower than avg
Panel avg: 115d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 241
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K130982.
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