Cleared Traditional

K223533 - Little Wave Arc (FDA 510(k) Clearance)

Also includes:
Little Wave Flip

Class I Physical Medicine device.

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

Submission Details

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.

Device Classification

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.