Cleared Traditional

K151797 - Nuocande Plastic Manual Wheelchair Model NKD L07

K151797 is an FDA 510(k) clearance for Nuocande Plastic Manual Wheelchair Mode..., manufactured by Ningbo Lecount Medical Technology Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K151797 · Ningbo Lecount Medical Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
54d
Days
Class 1
Risk

K151797 is an FDA 510(k) clearance for the Nuocande Plastic Manual Wheelchair Model NKD L07. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Ningbo Lecount Medical Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on August 25, 2015 after a review of 54 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.

FDA 510(k) Submission Details - K151797

510(k) Number K151797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date August 25, 2015
Days to Decision 54 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
62d faster than avg
Panel avg: 116d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

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

Manton Business and Technology Services
CHARLES SHEN

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 398
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K151797.
SUNTEC Mechanical Wheelchair, model ST-WL-1000
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GEN_3
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