Cleared Traditional

K171017 - Convaid Flyer FL12, FL13, FL14, FL15 and FL16 (FDA 510(k) Clearance)

Also includes:
Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T

Class I Physical Medicine device.

K171017 · Convaid Products, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
196d
Days
Class 1
Risk

K171017 is an FDA 510(k) clearance for the Convaid Flyer FL12, FL13, FL14, FL15 and FL16. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Convaid Products, LLC (Torrance, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 196 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 Convaid Products, LLC devices

Submission Details

510(k) Number K171017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2017
Decision Date October 18, 2017
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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 K171017.
Manual Wheelchair (7101L, 7102LHD)
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