Cleared Traditional

Little Wave Clik, Rogue XP, Little Wave XP, Spark (K223527) - FDA 510(k) Clearance

Class I Physical Medicine device.

K223527 · Ki Mobility, LLC · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
281d
Days
Class 1
Risk

K223527 is an FDA 510(k) clearance for the Little Wave Clik, Rogue XP, Little Wave XP, Spark. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Ki Mobility, LLC (Stevens Point, US). The FDA issued a Cleared decision on August 31, 2023 after a review of 281 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 Ki Mobility, LLC devices

Submission Details

510(k) Number K223527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2022
Decision Date August 31, 2023
Days to Decision 281 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
166d slower than avg
Panel avg: 115d · This submission: 281d
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 76
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K223527.
Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
K232198 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS
K232199 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2023
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
K200583 · Ki Mobility, LLC · Sep 2023
MA012 Aluminum wheelchair, MS019 steel wheelchair
K231750 · Sichuan Ast Medical Equipment Co., Ltd. · Aug 2023
Manual Wheelchair (A006)
K231110 · Ningbo Shenyu Medical Equipment Co.,Ltd · Jun 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
K231320 · Zhenjiang Assure Medical Equipment Co., Ltd. · Jun 2023