Cleared Traditional

K160031 - Quickie Pulse (Models 6BC

K160031 is an FDA 510(k) clearance for Quickie Pulse (Models 6BC, manufactured by Sunrise Medical (Us), LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K160031 · Sunrise Medical (Us), LLC · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
189d
Days
Class 2
Risk

K160031 is an FDA 510(k) clearance for the Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Model.... Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sunrise Medical (Us), LLC (Fresno, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 189 days - an extended review cycle.

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. 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 Sunrise Medical (Us), LLC devices

FDA 510(k) Submission Details - K160031

510(k) Number K160031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2016
Decision Date July 14, 2016
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 221
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K160031.
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
K173313 · Eurogreen International, Inc. · Feb 2018
SupaChair Powered Wheelchair
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Invacare® TDX® SP2 Power Wheelchair
K170507 · Invacare Corporation · Jul 2017
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
TDX SP2 POWER WHEECHAIR
K141783 · Invacare Corporation · Jan 2015