Cleared Traditional

K171017 - Convaid Flyer FL12, FL13, FL14, FL15 and FL16

Also marketed or referenced as:
Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T

K171017 is an FDA 510(k) clearance for Convaid Flyer FL12, manufactured by Convaid Products, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K171017 · Convaid Products, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K171017

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 116d · This submission: 196d
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 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K171017.
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · Sichuan Ast Medical Equipment Co., Ltd. · Sep 2018
Athena 190
K173360 · Medical Rehab Products, LLC · May 2018
Merits Model R106/R136 Rehab Wheelchair
K170517 · Merits Healthcare Industries (Suzhou) Co., Ltd. · Nov 2017
Wheelchair
K163352 · Kunshan Hi-Fortune Health Products Co., Ltd. · Jul 2017
Stellar LEAP
K163432 · Pdg Product Design Group, Inc. · Jun 2017
Winner Transfer Wheelchair
K162328 · Winner SG Pte, Ltd. · May 2017
K171017 · Convaid Flyer FL12, FL13, FL14, FL15 and FL16
Download PDF FDA Summary Convaid Products, LLC