A-200 Powered Wheelchair
510(k) K052706
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052706 | Date27 Dec 2005 | 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- Withdrawn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
- 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, 18 Sep 2026
The A-200 Powered Wheelchair is a motorised mobility device designed for individuals requiring powered assistance to navigate environments independently. It falls under the category of powered wheelchairs and is intended to provide enhanced mobility for users with limited ambulatory capacity, supporting both indoor and outdoor use.
This device is supplied as a reusable, non-sterile medical product, intended for clinical and home use. It is classified as a Class II device under FDA regulations and has received FDA 510K clearance. The wheelchair is manufactured by Otto Bock HealthCare LP and is available in various configurations, as indicated by the multiple FEI numbers. Storage and maintenance instructions are provided in the accompanying documentation to ensure proper functionality and safety.
Other devices from Otto Bock HealthCare LP
Questions
AI-generated answers, 18 Sep 2026
What types of environments is the A-200 Powered Wheelchair designed to be used in?
The A-200 Powered Wheelchair is specifically designed for both indoor and outdoor use, providing enhanced mobility for individuals who require powered assistance but have limited ambulatory capacity. Its versatility makes it suitable for navigating homes, clinics, and outdoor spaces.
Is the A-200 Powered Wheelchair intended for single-use or can it be reused?
The A-200 Powered Wheelchair is a reusable device, not intended for single-use. It is supplied as a non-sterile medical product for both clinical and home use, and proper storage and maintenance instructions are provided to ensure its longevity and functionality.
How many different configurations or models are available for the A-200 Powered Wheelchair?
The A-200 Powered Wheelchair comes in multiple configurations, as indicated by the extensive list of FEI numbers (e.g., 3014522447, 3021071770, etc.). These variations likely cater to different user needs, such as weight capacity, seating options, or additional features, allowing for customization based on individual requirements.
What kind of regulatory clearance does the A-200 Powered Wheelchair have, and how was it determined?
The A-200 Powered Wheelchair has received FDA 510K clearance, which means it was determined to be *substantially equivalent* to a legally marketed device in its category. The clearance was granted under a traditional review process by the FDA’s Physical Medicine (PM) Advisory Committee, confirming its compliance with regulatory standards for powered wheelchairs.
Where can I find guidance on how to properly store and maintain the A-200 Powered Wheelchair?
Storage and maintenance instructions for the A-200 Powered Wheelchair are included in the accompanying documentation provided by Otto Bock HealthCare LP. These guidelines ensure the wheelchair remains functional, safe, and reliable for both clinical and home use over time.