Cleared Traditional

K172384 - Quickie(r) Q700-UP M

K172384 is an FDA 510(k) clearance for Quickie(r) Q700-UP M, manufactured by Sunrise Medical (Us), LLC. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K172384 · Sunrise Medical (Us), LLC · Physical Medicine device
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Jan 2018
Decision
161d
Days
Class 2
Risk

K172384 is an FDA 510(k) clearance for the Quickie(r) Q700-UP M. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Sunrise Medical (Us), LLC (Fresno, US). The FDA issued a Cleared decision on January 16, 2018 after a review of 161 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 - K172384

510(k) Number K172384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date January 16, 2018
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 10
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K172384.
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LEVO-STAND-UP WHEELCHAIR
K790265 · Marion Laboratories, Inc. · Feb 1979