Cleared Traditional

K223527 - Little Wave Clik

K223527 is an FDA 510(k) clearance for Little Wave Clik, manufactured by Ki Mobility, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K223527 · Ki Mobility, LLC · Physical Medicine device
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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

FDA 510(k) Submission Details - K223527

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.

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 92
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