Cleared Traditional

Ki Power Tilt System (K201869) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201869 · Ki Mobility, LLC · Physical Medicine device
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Sep 2023
Decision
1155d
Days
Class 2
Risk

K201869 is an FDA 510(k) clearance for the Ki Power Tilt System. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Ki Mobility, LLC (Stevens Point, US). The FDA issued a Cleared decision on September 5, 2023 after a review of 1155 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Ki Mobility, LLC devices

Submission Details

510(k) Number K201869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2020
Decision Date September 05, 2023
Days to Decision 1155 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
1040d slower than avg
Panel avg: 115d · This submission: 1155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 170
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K201869.
Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
K231868 · Shanghai Bangbang Robotics Co., Ltd. · Oct 2023
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
K232193 · Yurob Rehabilitation Medical Co., Ltd. · Sep 2023
Power wheelchair (Model:BC-EA8000)
K232121 · Ningbo Baichen Medical Devices Co., Ltd. · Sep 2023
AMP by Method Mobility, AMP Plus (or +) by Method Mobility
K231032 · Method Mobility · May 2023
Electric Wheelchair
K223393 · Shanghai Bangbang Robotics Co., Ltd. · Mar 2023
KLICK (VARIANTS: POWER, RACE, MONSTER)
K222502 · Klaxon Mobility GmbH · Dec 2022