Cleared Traditional

K222711 - HS186B Scooter

K222711 is the FDA 510(k) clearance for HS186B Scooter by Suzhou Master Machinery Manufacturing Co.,Ltd. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K222711 · Suzhou Master Machinery Manufacturing Co.,Ltd · Physical Medicine device
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Jan 2023
Decision
123d
Days
Class 2
Risk

K222711 is an FDA 510(k) clearance for the HS186B Scooter. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan City, CN). The FDA issued a Cleared decision on January 9, 2023 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Master Machinery Manufacturing Co.,Ltd devices

Submission Details

510(k) Number K222711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2022
Decision Date January 09, 2023
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 Peers - INI Vehicle, Motorized 3-wheeled

All 79
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K222711.
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