Cleared Traditional

K251638 - Mobility Scooter (MS160C) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251638 · Suzhou Master Machinery Manufacturing Co.,Ltd · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
54d
Days
Class 2
Risk

K251638 is an FDA 510(k) clearance for the Mobility Scooter (MS160C). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan, CN). The FDA issued a Cleared decision on July 22, 2025 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 890.3800 - 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 Suzhou Master Machinery Manufacturing Co.,Ltd devices

Submission Details

510(k) Number K251638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date July 22, 2025
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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 - INI Vehicle, Motorized 3-wheeled

All 343
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K251638.
Mobility Scooter (X-12, X-14, X-17)
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Electrical Scooter (SM4226)
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Power Mobility Scooter (MJMA01, MJMA02)
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Mobility Scooter (CL-Q3, CL-Q4)
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Electric Scooter (DDF100)
K252275 · Zhejiang Nysin Medical Co., Ltd. · Jan 2026