Cleared Traditional

K261232 - IERO Mobility Scooter (IERO-01)

K261232 is an FDA 510(k) clearance for IERO Mobility Scooter (IERO-01), manufactured by Jochu Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K261232 · Jochu Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
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Jul 2026
Decision
90d
Days
Class 2
Risk

K261232 is an FDA 510(k) clearance for the IERO Mobility Scooter (IERO-01). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Jochu Technology Co., Ltd. (Hsin Chu, TW). The FDA issued a Cleared decision on July 14, 2026 after a review of 90 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 Jochu Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261232

510(k) Number K261232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2026
Decision Date July 14, 2026
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

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 208
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K261232.
Mobility Scooter (W3465, W3902 (S50 Carbon))
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Mobility Scooter (W3483, W3483A)
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Mobility Scooter (R200)
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Virgo Mobility Scooter (Virgo-D,Virgo-F)
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Scooter (YD-03)
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Mobility Scooter (Air Carbon)
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