Heartway Power Mobility Scooter S11
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101143 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 Heartway Power Mobility Scooter S11 is a motorized three-wheeled mobility device designed for individuals requiring assistance with ambulation. It falls under the category of motorized mobility aids, providing powered propulsion to enhance mobility for users with limited mobility or physical disabilities.
This device is intended for use in home, community, or clinical settings and is supplied as a reusable mobility aid. It has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for physical medicine applications. The scooter is not classified as MRI-safe, and its specifications include multiple registration numbers under the regulation number 890.3800. It is manufactured by Heartway Medical Products Co., Ltd., based in Taichung, Taiwan.
Frequently asked questions
What settings can the Heartway Power Mobility Scooter S11 be used in, and how is it intended to assist users?
The Heartway Power Mobility Scooter S11 is designed for use in home, community, or clinical environments. It provides powered propulsion to assist individuals with limited mobility or physical disabilities, helping them move independently without relying solely on manual effort.
Is the Heartway Power Mobility Scooter S11 reusable or single-use, and how should it be maintained?
The Heartway Power Mobility Scooter S11 is supplied as a reusable mobility aid. Since it is not classified as single-use, proper maintenance—including regular cleaning, battery care, and mechanical checks—is essential to ensure safe and reliable operation over time.
Does the Heartway Power Mobility Scooter S11 have any special considerations for use in medical imaging environments?
No, the Heartway Power Mobility Scooter S11 is not MRI-safe, meaning it should not be used in or near MRI machines, as it could interfere with imaging or pose safety risks during scans.
What regulatory approvals does the Heartway Power Mobility Scooter S11 hold, and how does this affect its use?
The scooter has received FDA 510(k) clearance and MDR authorization, confirming compliance with regulatory standards for motorized mobility aids under the classification for physical medicine. This means it meets safety and performance requirements for use in clinical and home settings as intended.
How can I verify the authenticity or registration details of a Heartway Power Mobility Scooter S11?
The device includes multiple registration numbers (e.g., 3033905189, 3012604975, etc.) under FDA’s regulation number 890.3800. These can be cross-referenced with the manufacturer’s records or FDA’s OpenFDA database to confirm authenticity. The scooter is also listed under product code INI and advisory committee PM (Physical Medicine).
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101143 | Class II | Active |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co., Ltd.
Sources (2)
- FDA 510(k) K101143 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 28, 2026