Powered Mobility Scooter (PMS105, GUT177, GCAT047)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K252590 ↗

FDA Product Code

INI

FDA applicant

Intradin (Shanghai) Machinery Co., Ltd.

Device Class

Class II

Regulation

21 CFR Part 890.3800

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Lift Chair

  Class I

  CE/MDR

• Bath Lift Cushion

  Class I

  CE/MDR

• Powered Mobility Scooter

  Class I

  CE/MDR

• Transfer Floor Lift

  Class I

  CE/MDR

• Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

  Class II

  FDA 510(k) K232692 Active Cleared 5 Sep 2024

• PlusTransfer Floor Lift-Plus

  Class I

  CE/MDR

See all devices from Intradin (Shanghai) Machinery Co., Ltd →

• What environments is this powered mobility scooter designed to operate in and how does it assist users?

  The Powered Mobility Scooter (PMS105, GUT177, GCAT047) is engineered for use in home, community, and clinical settings, providing independent mobility assistance. It features electric motors, steering, and braking systems to help users navigate both indoor and outdoor environments safely and efficiently, making it suitable for daily activities in various locations.

• Is this device single-use or reusable, and what does that mean for maintenance?

  This scooter is reusable, meaning it is designed for long-term use with proper care. Since it is classified as a reusable medical device, regular maintenance—such as battery checks, tire pressure adjustments, and mechanical inspections—will be required to ensure safety and performance over time. The manufacturer’s guidelines should be followed for cleaning and upkeep.

• What regulatory pathways has this device followed, and what does that imply for its safety and compliance?

  The Powered Mobility Scooter (PMS105) has received FDA 510(k) clearance under the Substantially Equivalent (SESE) standard, as well as MDR authorization, confirming it meets U.S. and EU safety, performance, and manufacturing requirements for Class II medical devices. This classification ensures it adheres to rigorous standards for powered mobility aids, including design, testing, and post-market surveillance.

• Are there multiple models or sizes available for this scooter, and how might that affect user selection?

  While the provided data lists multiple registration numbers and FEI codes, it does not specify distinct models or sizes. However, the PMS105, GUT177, and GCAT047 designations suggest potential variations may exist. Users should consult the manufacturer’s documentation or sales team to determine if specific configurations (e.g., weight capacity, folding options, or battery range) align with their needs, as these factors can influence usability and suitability.

• How should this scooter be stored to maintain its functionality and longevity?

  Since this is a reusable device, proper storage is critical to preserve its components. The scooter should be stored in a dry, indoor environment away from direct sunlight, extreme temperatures, and moisture to prevent damage to the battery, electronics, and frame. If not in use for extended periods, the manufacturer’s instructions should be followed for battery maintenance (e.g., partial discharge) to avoid degradation.