Folding Mobility Scooter (KD101)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252502 FDA 510(k)
- FDA Product Code
- INI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3800 FDA 510(k)
- Regulation Number
- 890.3800 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Folding Mobility Scooter (KD101) is a motorized 3-wheeled vehicle designed to assist with mobility. It is classified as a medical device in the physical medicine specialty category.
This device is manufactured by Nanjing Kangni Smart Technology Co., Ltd. and received FDA 510(k) clearance on October 6, 2025, under number K252502. It is regulated under 21 CFR 890.3800 and is a Class II medical device.
Frequently asked questions
What is the Folding Mobility Scooter KD101 used for?
The Folding Mobility Scooter (KD101) is a motorized 3-wheeled vehicle designed to assist with mobility. It is classified as a medical device in the physical medicine specialty category, helping individuals with mobility challenges maintain independence.
What is the regulatory status of the Folding Mobility Scooter KD101?
The Folding Mobility Scooter (KD101) received FDA 510(k) clearance on October 6, 2025, under number K252502. It is regulated under 21 CFR 890.3800 and is classified as a Class II medical device.
Is the Folding Mobility Scooter KD101 reusable or single-use?
The device data does not specify whether the Folding Mobility Scooter (KD101) is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer or product documentation.
What are the key specifications of the Folding Mobility Scooter KD101?
The Folding Mobility Scooter (KD101) is a motorized 3-wheeled vehicle with folding capability. It is manufactured by Nanjing Kangni Smart Technology Co., Ltd. and has received FDA 510(k) clearance. Specific dimensions, weight capacity, and battery life details are not provided in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Folding Mobility Scooter (KD101) (K252502) — FDA 510 (k) | Innolitics, PDF October 6, 2025 - accessdata.fda.gov, Folding Mobility Scooter (KD101) — FDA 510 (k) K252502 | MedTracker, Folding Mobility Scooter (KD101) (K252502) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252502 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanjing Kangni Smart Technology Co., Ltd
- FDA Applicant
- Nanjing Kangni Smart Technology Co., Ltd.
Sources (1)
- FDA 510(k) K252502 24 fields · synced Sep 27, 2026