AMP by Method Mobility, AMP Plus by Method Mobility
510(k) K231032
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231032 | Date10 May 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- AMP by Method Mobility, AMP Plus (or +) by Method Mobility
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AMP by Method Mobility is a Powered Wheelchair, Manual (per FDA classification ITI, Device Class II) designed to provide powered assistance to manual wheelchairs. It enhances mobility for users capable of operating both manual and powered wheelchairs by integrating motorised propulsion into the handrims, reducing user fatigue during propulsion.
The AMP is supplied as a modular add-on system for existing manual wheelchairs, requiring no permanent modifications to the base chair. It is intended for single-use or reusable applications, depending on manufacturer guidelines, and is not classified as MRI-safe. Sizes and configurations are tailored to fit standard manual wheelchair frames, with installation and maintenance performed by trained professionals. The device holds an FDA 510K clearance under the Physical Medicine specialty, with registration number 9615350 and regulation 890.3860.
Other devices from Method Mobility
Questions
AI-generated answers, 19 Sep 2026
What is the AMP by Method Mobility designed to do for users who already have a manual wheelchair?
The AMP is a powered assist system that integrates motorized propulsion into the handrims of existing manual wheelchairs. It’s designed to reduce user fatigue during propulsion by providing powered assistance, allowing individuals who can operate both manual and powered wheelchairs to maintain mobility with less effort.
Does the AMP require permanent modifications to the wheelchair frame, or can it be added as a modular system?
The AMP is supplied as a modular add-on system, meaning it can be installed on existing manual wheelchairs without requiring permanent modifications to the base chair. This makes it a flexible solution for users who want to enhance their current mobility setup.
How is the AMP intended to be used—is it meant for single-use or reusable applications?
The AMP can be used for either single-use or reusable applications, depending on the manufacturer’s guidelines. This flexibility allows users and facilities to choose the most practical approach based on their needs and usage patterns.
Can the AMP be used in an MRI environment, or does it have any restrictions?
The AMP is explicitly stated as *not* MRI-safe, so it should not be used in MRI environments. Users should avoid bringing the device into areas where MRI procedures are performed.
What regulatory pathway was followed for the AMP’s clearance, and what does that mean for buyers?
The AMP holds an FDA 510(k) clearance under the Physical Medicine specialty, classified as a Powered Wheelchair (Device Class II). This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA requirements for safety and effectiveness. Buyers can rely on this clearance as evidence of regulatory compliance.