Cleared Traditional

Manual Wheelchair (A006) (K231110) - FDA 510(k) Clearance

Class I Physical Medicine device.

K231110 · Ningbo Shenyu Medical Equipment Co.,Ltd · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
58d
Days
Class 1
Risk

K231110 is an FDA 510(k) clearance for the Manual Wheelchair (A006). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Ningbo Shenyu Medical Equipment Co.,Ltd (Yuyao, CN). The FDA issued a Cleared decision on June 16, 2023 after a review of 58 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 Ningbo Shenyu Medical Equipment Co.,Ltd devices

Submission Details

510(k) Number K231110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2023
Decision Date June 16, 2023
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 52
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K231110.
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
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MA012 Aluminum wheelchair, MS019 steel wheelchair
K231750 · Sichuan Ast Medical Equipment Co., Ltd. · Aug 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
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K220698 · Panthera AB · Feb 2023
SUPERTILT PLUS (STP)
K221435 · Power Plus Mobility · Oct 2022