Cleared Traditional

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL (K200583) - FDA 510(k) Clearance

Class I Physical Medicine device.

K200583 · Ki Mobility, LLC · Physical Medicine device
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Sep 2023
Decision
1278d
Days
Class 1
Risk

K200583 is an FDA 510(k) clearance for the Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL. 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 September 5, 2023 after a review of 1278 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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: 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 K200583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2020
Decision Date September 05, 2023
Days to Decision 1278 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
1163d slower than avg
Panel avg: 115d · This submission: 1278d
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 K200583.
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE
K232230 · Zhenjiang Assure Medical Equipment Co., Ltd. · Oct 2023
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
Little Wave Clik, Rogue XP, Little Wave XP, Spark
K223527 · Ki Mobility, LLC · Aug 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