Cleared Special

Powered Mobility Scooter (K250027) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250027 · Intradin (Shanghai) Machinery Co., Ltd. · Physical Medicine device
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Feb 2025
Decision
46d
Days
Class 2
Risk

K250027 is an FDA 510(k) clearance for the Powered Mobility Scooter. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Intradin (Shanghai) Machinery Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 21, 2025 after a review of 46 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Intradin (Shanghai) Machinery Co., Ltd. devices

Submission Details

510(k) Number K250027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2025
Decision Date February 21, 2025
Days to Decision 46 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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.
Ariel Xiang

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 74
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K250027.
Mobility Scooter (JT10)
K243102 · Jiangxi Jiangte Electric Vehicle Co., Ltd. · Jun 2025
Magnesium alloy scooter (RS100)
K250533 · Taizhou Reach Technology Co., Ltd. · May 2025
Mobility Scooter (Model X-01, X-02)
K242975 · Wuyi Aichi Industry & Trade Co., Ltd. · May 2025
Mobility Scooter (MS160A)
K242982 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jan 2025
Mobility Scooter (S-01)
K242714 · Zhejiang Seedream Medical Equipment Co., Ltd. · Jan 2025
Electrical Scooter, WT-T4SU
K240590 · W'U'S Tech Co., Ltd. · Jan 2025