Cleared Traditional

K253075 - Mobility scooter (Air Classic)

Also marketed or referenced as:
Mobility scooter (Air Traveller) Mobility scooter (Air Traveller2.0)

K253075 is an FDA 510(k) clearance for Mobility scooter (Air Classic), manufactured by Suzhou Sweetrich Vehicle Industry 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 108-day FDA review.

K253075 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
108d
Days
Class 2
Risk

K253075 is an FDA 510(k) clearance for the Mobility scooter (Air Classic). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 9, 2026 after a review of 108 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 Sweetrich Vehicle Industry Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253075

510(k) Number K253075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date January 09, 2026
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
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.
Ariel Xiang

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 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K253075.
Electric Scooter (DDF100)
K252275 · Zhejiang Nysin Medical Co., Ltd. · Jan 2026
Electric Scooter (Mojo-T580)
K252347 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026
Electric Scooter (Mojo-T330)
K252349 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026
Mobility Scooter (BC-MS310)
K252817 · Ningbo Baichen Medical Devices Co., Ltd. · Jan 2026
Electric Scooter (S202572J, S2060, M2089, S2050)
K252835 · Guangdong Prestige Technology Co., Ltd. · Dec 2025
Mobility Scooter (T5)
K252588 · Zhejiang Taotao Vehicle Co., Ltd. · Dec 2025