Identifiers
- 510(k) Number
- K212090 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 Electric Scooter is a motorized 3-wheeled vehicle designed to assist individuals with mobility needs. It functions as a powered mobility device to facilitate travel for users.
This device is manufactured by Anhui Jbh Medical Apparatus Co., Ltd. and has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 890.3800.
Frequently asked questions
What is the primary purpose of the Electric Scooter?
The Electric Scooter is a motorized 3-wheeled vehicle designed to assist individuals with mobility needs by facilitating travel as a powered mobility device.
Is this device regulated by the FDA?
Yes, this device has received FDA 510(k) clearance and is classified as a class 2 medical device under regulation number 890.3800.
Who is the manufacturer of this mobility device?
The Electric Scooter is manufactured by Anhui JBH Medical Apparatus Co., Ltd., located in Chuzhou, China.
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: JBH Medical - Leading Electric Wheelchair & Mobility Scooter Mfr, Company Overview - Anhui Jbh Medical Apparatus Co., Ltd., JBH Mobility Scooter | Portable Folding Aluminum & Carbon ... - JBH Medical, 2026 Electric Scooter - Anhui Jbh Medical Apparatus Co., Ltd. - page 1.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212090 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anhui Jbh Medical Apparatus Co., Ltd
- FDA Applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
Sources (1)
- FDA 510(k) K212090 24 fields · synced Sep 26, 2026