Comfort Various Standing Wheelchair Hero 2

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Comfort Various of Standing Wheelchair, Hero 2

510(k) Number

K031618 ↗

FDA Product Code

IPL

Device Class

Class II

Regulation

21 CFR Part 890.3900

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Comfort Scooter Model Ly-EW406

  Class II

  FDA 510(k) K063030 Active Cleared 4 Dec 2006

• Comfort Powered Wheelchair, Conqueror Ly-Eb 202

  Class II

  FDA 510(k) K030355 Active Cleared 20 May 2003

• Comfort Electric Scooter, Ly-EW408

  Class II

  FDA 510(k) K072712 Active Cleared 31 Oct 2007

• Comfort Dreamrider Scooter LY-EW402

  Class II

  FDA 510(k) K021910 Active Cleared 11 Oct 2002

• Comfort Powered Wheelchair, Ly-Eb 206

  Class II

  FDA 510(k) K072711 Active Cleared 31 Oct 2007

• Comfort Wheelchairs

  Class I

  FDA 510(k) K020451 Active Cleared 14 Mar 2002

See all devices from Comfort Orthopedic Co., Ltd. →

• What clinical settings is this standing wheelchair designed for and how does it differ from a standard wheelchair?

  The Comfort Various Standing Wheelchair Hero 2 is designed for use in both clinical (e.g., rehabilitation centers) and home settings. Unlike a standard wheelchair, it combines manual or powered mobility with adjustable features to help users transition between seated and standing positions, supporting weight-bearing and posture management for individuals with limited independent mobility.

• Is this wheelchair intended for single-use or reusable applications, and are there any sterility requirements?

  This device is explicitly supplied as a reusable mobility aid, with no specified sterility requirements. It is not designated for single-use, so cleaning and maintenance protocols will apply for repeated use in clinical or home environments.

• How do I determine if the model I need matches the regulatory configurations listed for this device?

  The Hero 2 is available in multiple configurations, each with its own FDA registration number (e.g., 3014653196, 3004908349). To confirm compatibility, check the specific model’s registration number against the list provided in the FDA’s OpenFDA database or the manufacturer’s documentation. These numbers correspond to variations in design or features but do not affect core functionality.

• What type of regulatory clearance does this wheelchair hold, and which advisory committee was involved in its review?

  The Comfort Various Standing Wheelchair Hero 2 holds a 510(k) clearance (K031618) under FDA regulation 890.3900, classified as substantially equivalent (SESE) to a predicate device. Its review was conducted by the Physical Medicine (PM) Advisory Committee, reflecting its intended use for mobility assistance in physical medicine settings.

• Are there any special storage or handling instructions for this wheelchair beyond standard mobility aids?

  While the device data does not specify unique storage requirements beyond typical mobility aids, reusable medical devices like this one should be stored in a clean, dry environment to prevent damage or contamination. Follow manufacturer guidelines for disassembly, cleaning, and maintenance to ensure longevity and compliance with clinical hygiene standards.