Powered Wheelchair Model B-600

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041210 ↗

FDA Product Code

ITI

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Trias (without Footshell)

  Class I

  CE/MDR

• Taleo service foot

  Class I

  CE/MDR

• Taleo Harmony service foot

  Class I

  CE/MDR

• Triton Service Foot

  Class I

  CE/MDR

• 1C62 Triton H, R, without footshell

  Class I

  CE/MDR

• 1C61 VS Trial Foot, L, Without Footshell

  Class I

  CE/MDR

See all devices from Otto Bock HealthCare LP →

• What environments is the Powered Wheelchair Model B-600 designed to be used in and how does this affect its maintenance requirements?

  The Powered Wheelchair Model B-600 is intended for use in both indoor and outdoor environments, providing mobility assistance in clinical, home, and community settings. Since it is reusable and non-sterile, maintenance requirements focus on ensuring durability and functionality across varied surfaces and conditions. The manufacturer recommends following their guidelines for regular upkeep, which likely includes cleaning, mechanical checks, and battery maintenance to accommodate its use in diverse settings.

• Is the Powered Wheelchair Model B-600 single-use or reusable, and what does this mean for its storage and handling?

  The Powered Wheelchair Model B-600 is explicitly designed as a reusable device, not single-use. This means it must be cleaned, inspected, and maintained between uses to ensure safety and functionality. Proper storage involves keeping it in a dry, protected environment away from direct sunlight or extreme temperatures, as outlined in the manufacturer’s guidelines to preserve its components and performance.

• How is the regulatory approval process for the Powered Wheelchair Model B-600 structured, and what does this imply for buyers or clinicians?

  The Powered Wheelchair Model B-600 received FDA 510(k) clearance under regulation 21 CFR 890.3860, with a traditional review process by the Physical Medicine (PM) Advisory Committee. This means the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets U.S. safety and performance standards. Buyers or clinicians can rely on this approval for distribution within the United States, though they should still adhere to manufacturer instructions for proper use and maintenance.

• What does the term ‘non-sterile’ mean for the Powered Wheelchair Model B-600, and how should clinicians or caregivers handle it?

  The Powered Wheelchair Model B-600 is non-sterile, meaning it is not intended for invasive procedures or sterile environments like operating rooms. For clinicians or caregivers, this implies routine cleaning with mild detergents and disinfectants (as recommended by the manufacturer) is sufficient to maintain hygiene. Sterilization is unnecessary, but thorough cleaning between uses—especially in shared or clinical settings—helps prevent contamination and ensures safe, long-term use.

• Are there multiple models or configurations of the Powered Wheelchair Model B-600, or is it a single standardized design?

  The provided data does not specify multiple models or configurations for the Powered Wheelchair Model B-600 itself, but the OpenFDA registration numbers suggest it may be available in various configurations or customizations (e.g., different wheel sizes, seating options, or power settings) under the same core model designation. For precise details on available sizes or features, buyers should consult Otto Bock Healthcare’s product catalog or contact their support team, as these variations are not explicitly outlined in the regulatory submission.