Cleared Traditional

Mobility Scooter (Models: W3431Q, W3431R) (K222507) - FDA 510(k) Clearance

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

K222507 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Physical Medicine device
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Feb 2023
Decision
194d
Days
Class 2
Risk

K222507 is an FDA 510(k) clearance for the Mobility Scooter (Models: W3431Q, W3431R). 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 February 28, 2023 after a review of 194 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

Submission Details

510(k) Number K222507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2022
Decision Date February 28, 2023
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
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 74
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K222507.
ATTO Mobility Scooter (ATTO)
K222703 · Moving Life, Ltd. · May 2023
Electric Scooter (Model: S3312)
K230615 · Guangdong Prestige Technology Co., Ltd. · May 2023
Electrical Scooter, WT-T4QP2
K222729 · Wu'S Tech Co., Ltd. · Mar 2023
eFOLDi Scooter, Lite
K223492 · Suntech UK , Ltd. · Feb 2023
HS186B Scooter
K222711 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jan 2023
Mobility Scooter, Model: W3331F
K222495 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Oct 2022