Cleared Traditional

K200583 - Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

K200583 is an FDA 510(k) clearance for Ki Mobility Focus CR, 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 1278-day FDA review.

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

FDA 510(k) Submission Details - K200583

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
1162d slower than avg
Panel avg: 116d · This submission: 1278d
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 324
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