Cleared Traditional

K252828 - Manual Wheelchair (W47) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K252828 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Physical Medicine device
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Dec 2025
Decision
91d
Days
Class 1
Risk

K252828 is an FDA 510(k) clearance for the Manual Wheelchair (W47). 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 December 5, 2025 after a review of 91 days - within the typical 510(k) review window.

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 Jiangsu Jumao X-Care Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K252828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2025
Decision Date December 05, 2025
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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

Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
Ariel Xiang

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 K252828.
Manual Wheelchair (7101L, 7102LHD)
K260121 · Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · Apr 2026
Manual Wheelchair (W50)
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2026
EmpowerRide NAVIGATOR
K251886 · Empower Ride, LLC · Jan 2026
Manual Wheelchair (W45)
K252825 · 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
Flexx Junior (FLX-J00, FLX-J50)
K250576 · Karma Mobility Co, Ltd. · Nov 2025