Cleared Traditional

K223533 - Little Wave Arc

Also marketed or referenced as:
Little Wave Flip

K223533 is an FDA 510(k) clearance for Little Wave Arc, manufactured by Ki Mobility, LLC. The device is a Class 1 Physical Medicine device with product code LBE cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K223533 · Ki Mobility, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
281d
Days
Class 1
Risk

K223533 is an FDA 510(k) clearance for the Little Wave Arc. Classified as Stroller, Adaptive (product code LBE), 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 - K223533

510(k) Number K223533 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.

LBE Device Classification - Class 1, General Controls

Product Code LBE Stroller, Adaptive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
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.