Cleared Traditional

K152827 - Weely Manual Wheelchair

K152827 is an FDA 510(k) clearance for Weely Manual Wheelchair, manufactured by Rupiani. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K152827 · Rupiani · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
143d
Days
Class 1
Risk

K152827 is an FDA 510(k) clearance for the Weely Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rupiani (Vaudex En Velin, FR). The FDA issued a Cleared decision on February 19, 2016 after a review of 143 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K152827

510(k) Number K152827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date February 19, 2016
Days to Decision 143 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
27d slower than avg
Panel avg: 116d · This submission: 143d
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 Consultant

Spectre Solutions, Inc.
Edward A Kroll

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 398
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K152827.
SUNCO Mechanical Wheelchair, model SKW-9003
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SUNTEC Mechanical Wheelchair, model ST-WL-1000
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MyOn HC Manual Wheelchair
K152536 · Invacare Corporation · Jan 2016
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K151893 · Freedom Designs, Inc. · Oct 2015