Cleared Traditional

K260237 - Mobility Scooter (X-12, X-14, X-17) (FDA 510(k) Clearance)

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

K260237 · Wuyi Aichi Industry and Trade Co., Ltd. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
86d
Days
Class 2
Risk

K260237 is an FDA 510(k) clearance for the Mobility Scooter (X-12, X-14, X-17). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Wuyi Aichi Industry and Trade Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on April 22, 2026 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 890.3800 - 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 Wuyi Aichi Industry and Trade Co., Ltd. devices

Submission Details

510(k) Number K260237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date April 22, 2026
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 SUNGO Management Consulting Co., Ltd.
Kiwi Xu

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 K260237.
Electrical Scooter (SM4226)
K252813 · Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Mar 2026
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · Nanjing Mijo Technology Co., Ltd. · Mar 2026
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 2026
Mobility Scooter (S3)
K253643 · Shenzhen Zhimahuaerkai Technology Co., Ltd. · Feb 2026
Electric Scooter (DDF100)
K252275 · Zhejiang Nysin Medical Co., Ltd. · Jan 2026
Electric Scooter (Mojo-T580)
K252347 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026