Access Mobility System
PMA P900050
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900050 | Date27 Jun 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Wheelchair, stair climbing
- PMA Number
- FDA Product Code
- IMK
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3890
- Advisory Committee
- Physical Medicine
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 20 Sep 2026
The Access Mobility System is a Wheelchair, Stair Climbing (per FDA classification IMK), designed to assist individuals with limited mobility in ascending and descending stairs while seated in a wheelchair. This device integrates with manual or power wheelchairs to provide controlled, step-by-step ascent, enhancing independence for users with physical impairments. Its primary function aligns with the Wheelchair, Stair Climbing nomenclature, enabling safe navigation of staircases in residential or low-rise environments.
The system is supplied as a standalone mobility aid, intended for use in home or institutional settings where stair access is required. It is not described as single-use or sterile, nor is MRI compatibility mentioned in the specifications. The device is regulated under FDA PMA (Premarket Approval) with PMA number P900050, reflecting its classification as a Class II medical device under regulation 890.3890. No details on sterilisation, reusable components, or specific storage conditions are provided in the available data.
Questions
AI-generated answers, 20 Sep 2026
What types of wheelchairs can the Access Mobility System integrate with, and how does it help users navigate stairs?
The Access Mobility System is designed to integrate with both manual and power wheelchairs, enabling users with limited mobility to safely ascend and descend stairs while seated. It provides controlled, step-by-step movement, which helps enhance independence for individuals with physical impairments in environments like homes or low-rise institutions where stair access is required.
Is the Access Mobility System intended for single-use or repeated use, and what are the storage requirements?
The available data does not specify whether the Access Mobility System or its components are single-use or reusable. Since no details on sterilization or storage conditions are provided, users should follow manufacturer guidelines (from Quest Technologies Corp.) for proper maintenance and storage to ensure safe and effective operation.
How is the Access Mobility System regulated by the FDA, and what does this mean for its use?
The Access Mobility System is regulated under the FDA’s Premarket Approval (PMA) process, with PMA number P900050, and classified as a Class II medical device under regulation 890.3890. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness before being approved for use in assisting individuals with stair climbing while seated in a wheelchair.
What kind of environments is the Access Mobility System intended for, and does it have any special compatibility considerations?
The system is supplied as a standalone mobility aid intended for use in home or institutional settings where stair access is required, particularly in residential or low-rise environments. There is no mention of MRI compatibility or specialized environmental constraints in the provided data, so standard indoor conditions should apply.