Cleared Traditional

K232230 - YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE (FDA 510(k) Clearance)

Also includes:
YJ-K1F 16 NDS YJ-K1F 18 NDE YJ-K1F 18 NDS YJ-K1F 20 NDE YJ-K1F 20 NDS YJ-K1F 18 NDEE YJ-K1F 16 VDE YJ-K1F 16 VDS YJ-K1F 18 VDE YJ-K1F 18 VDS YJ-K1F 20 VDE YJ-K1F 20 VDS YJ-K2 16 VDFE YJ-K2 16 VDFS YJ-K2 18 VDFE YJ-K2 18 VDFS YJ-K2 20 VDFE YJ-K2 20 VDFS YJ-K1G 18 NFFE YJ-K1G 18 NFFS YJ-K2TC 16 NAFE YJ-K2TC 18 NAFE YJ-K2TC 20 NAFE)

Class I Physical Medicine device.

K232230 · Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
68d
Days
Class 1
Risk

K232230 is an FDA 510(k) clearance for the YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang City, CN). The FDA issued a Cleared decision on October 3, 2023 after a review of 68 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.

View all Zhenjiang Assure Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K232230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2023
Decision Date October 03, 2023
Days to Decision 68 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
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 453
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K232230.
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