Cleared Traditional

K190534 - Manual Wheelchair SIVFH2A102 (FDA 510(k) Clearance)

Class I Physical Medicine device.

K190534 · Jiangsu Horizon Medical Science & Technology Co., Ltd. · Physical Medicine device
May 2019
Decision
86d
Days
Class 1
Risk

K190534 is an FDA 510(k) clearance for the Manual Wheelchair SIVFH2A102. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jiangsu Horizon Medical Science & Technology Co., Ltd. (Situ Town, Danyang City, CN). The FDA issued a Cleared decision on May 29, 2019 after a review of 86 days — a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment — the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K190534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date May 29, 2019
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 152d · This submission: 86d
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 13
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K190534.
Manual Wheelchair (W50)
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2026
EmpowerRide NAVIGATOR
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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
Flexx Junior (FLX-J00, FLX-J50)
K250576 · Karma Mobility Co, Ltd. · Nov 2025