Cleared Traditional

Mobility Scooter (BBR-Q40-01) (K251799) - FDA 510(k) Clearance

Also marketed or referenced as:
Mobility Scooter (BBR-Q40-02) Mobility Scooter (BBR-Q40-03) Mobility Scooter (BBR-Q40-04) Mobility Scooter (BBR-Q40-05) Mobility Scooter (BBR-Q40-06)

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

K251799 · Jiangsu Bangbang Intelligent Technology Co., Ltd. · Physical Medicine device
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Sep 2025
Decision
110d
Days
Class 2
Risk

K251799 is an FDA 510(k) clearance for the Mobility Scooter (BBR-Q40-01). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Jiangsu Bangbang Intelligent Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 30, 2025 after a review of 110 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 Jiangsu Bangbang Intelligent Technology Co., Ltd. devices

Submission Details

510(k) Number K251799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2025
Decision Date September 30, 2025
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
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 Co., Ltd.
Sandra Jiang

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 K251799.
Mobility Scooter (T5)
K252588 · Zhejiang Taotao Vehicle Co., Ltd. · Dec 2025
Powered Mobility Scooter (PMS105, GUT177, GCAT047)
K252590 · Intradin (Shanghai) Machinery Co., Ltd. · Nov 2025
Folding Mobility Scooter (KD101)
K252502 · Nanjing Kangni Smart Technology Co., Ltd. · Oct 2025
Mobility Scooter (MS160C)
K251638 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jul 2025
Mobility Scooter (JT10)
K243102 · Jiangxi Jiangte Electric Vehicle Co., Ltd. · Jun 2025
Magnesium alloy scooter (RS100)
K250533 · Taizhou Reach Technology Co., Ltd. · May 2025