Cleared Traditional

K200466 - Manual Wheelchair (Model W28) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K200466 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Physical Medicine device
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Jun 2021
Decision
474d
Days
Class 1
Risk

K200466 is an FDA 510(k) clearance for the Manual Wheelchair (Model W28). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on June 14, 2021 after a review of 474 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 Jiangsu Jumao X-Care Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K200466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2020
Decision Date June 14, 2021
Days to Decision 474 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
359d slower than avg
Panel avg: 115d · This submission: 474d
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 Consultant

Guangzhou Junyi Information Technology Co., Ltd.
Jinghua Zhou

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 453
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K200466.
Manual Wheelchair (7101L, 7102LHD)
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Manual Wheelchair (W50)
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Manual Wheelchair (W45)
K252825 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Dec 2025
Manual Wheelchair (W47)
K252828 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Dec 2025
Manual Wheelchair (HM305-Air1, HM305-Air2)
K252687 · Suzhou Master Machinery Manufacturing Co.,Ltd · Nov 2025