Cleared Traditional

K220207 - Mobility Scooter, Model W3468 (FDA 510(k) Clearance)

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

K220207 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Physical Medicine device
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Mar 2022
Decision
58d
Days
Class 2
Risk

K220207 is an FDA 510(k) clearance for the Mobility Scooter, Model W3468. 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 March 24, 2022 after a review of 58 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 Zhejiang Innuovo Rehabilitation Devices Co.,Ltd devices

Submission Details

510(k) Number K220207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2022
Decision Date March 24, 2022
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 Company Limited.
Jarvis Wu

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 K220207.
Mobility Scooter (X-12, X-14, X-17)
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Electrical Scooter (SM4226)
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Power Mobility Scooter (MJMA01, MJMA02)
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Mobility Scooter (CL-Q3, CL-Q4)
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Mobility Scooter (S3)
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Electric Scooter (DDF100)
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