Cleared Traditional

K260176 - Mobility Scooter (W3483, W3483A)

K260176 is an FDA 510(k) clearance for Mobility Scooter (W3483, manufactured by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K260176 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Physical Medicine device
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Aug 2026
Decision
201d
Days
Class 2
Risk

K260176 is an FDA 510(k) clearance for the Mobility Scooter (W3483, W3483A). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (Dongyang, CN). The FDA issued a Cleared decision on August 10, 2026 after a review of 201 days - an extended review 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: 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 Zhejiang Innuovo Rehabilitation Devices Co.,Ltd devices

FDA 510(k) Submission Details - K260176

510(k) Number K260176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2026
Decision Date August 10, 2026
Days to Decision 201 days
Submission Type Traditional
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
86d slower than avg
Panel avg: 115d · This submission: 201d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Ivy 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 208
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K260176.
Mobility Scooter (W3465, W3902 (S50 Carbon))
K260094 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Aug 2026
IERO Mobility Scooter (IERO-01)
K261232 · Jochu Technology Co., Ltd. · Jul 2026
Mobility Scooter (R200)
K261163 · Yongkang Ruihe Metal Product Co., Ltd. · Jul 2026
Virgo Mobility Scooter (Virgo-D,Virgo-F)
K253257 · Jiangsu Intco Medical Products Co., Ltd. · Jun 2026
Scooter (YD-03)
K253600 · Yurob Rehabilitation Medical Co., Ltd. · Jun 2026
Mobility Scooter (Air Carbon)
K260717 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · May 2026