Powered Wheelchair Model C-1000
510(k) K041211
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041211 | Date1 Oct 2004 | 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- Withdrawn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 Powered Wheelchair Model C-1000 is a motorized mobility device designed to assist individuals with limited mobility in independent movement. It is classified as a powered wheelchair, providing electric propulsion for users who require enhanced mobility support in various environments, including indoor and outdoor settings.
This device is intended for clinical use in physical medicine settings and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. Supplied as a reusable, non-sterile product, it is regulated under FDA regulation number 890.3860 and is intended for use in mobility assistance. The wheelchair is manufactured by Otto Bock Healthcare LP and is available in configurations corresponding to the listed FEI numbers for distribution and inventory tracking.
Other devices from Otto Bock HealthCare LP
Questions
AI-generated answers, 18 Sep 2026
What types of environments is the Powered Wheelchair Model C-1000 designed to operate in?
The Powered Wheelchair Model C-1000 is specifically designed for use in both indoor and outdoor settings. Its motorized propulsion system provides enhanced mobility support for individuals with limited mobility, making it suitable for a variety of environments where traditional manual wheelchairs may be less practical.
Is the Powered Wheelchair Model C-1000 intended for single-use or can it be reused?
The Powered Wheelchair Model C-1000 is supplied as a reusable device, meaning it is not intended for single-use. It is designed for long-term use by individuals requiring mobility assistance, provided it is properly maintained and serviced.
How is the wheelchair’s regulatory status determined, and what does that mean for buyers?
The Powered Wheelchair Model C-1000 received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. 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 for use in clinical settings like physical medicine.
How do I identify the specific configuration or model of the Powered Wheelchair Model C-1000 in inventory?
The Powered Wheelchair Model C-1000 is tracked using multiple FEI (Facility Equipment Identifier) numbers, which are unique identifiers assigned for distribution and inventory purposes. These numbers include a wide range of values (e.g., 3014522447, 3021071770, etc.), so checking the FEI number on the device will help confirm its specific configuration or model.
What type of maintenance or cleaning is required for the Powered Wheelchair Model C-1000?
Since the Powered Wheelchair Model C-1000 is a reusable, non-sterile device, it requires regular cleaning and maintenance to ensure safe and effective use. While the data does not specify cleaning protocols, typical practices for powered wheelchairs include wiping down surfaces with mild disinfectants, inspecting mechanical components, and following manufacturer guidelines for battery care and motor maintenance. Always refer to Otto Bock Healthcare LP’s instructions for proper upkeep.