AMIGO RT

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

510(k) Number

K981121 ↗

FDA Product Code

INI

Device Class

Class II

Regulation

21 CFR Part 890.3800

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Amigo Model 680000 (Amigo Excite F 350)

  Class II

  FDA 510(k) K992619 Active Cleared 25 Oct 1999

• Amigo Wheelchair

  Class II

  FDA 510(k) K010503 Active Cleared 6 Jul 2001

• Amigo J-9

  Class II

  FDA 510(k) K940334 Active Cleared 18 May 1994

• Amigo Model 590000

  Class II

  FDA 510(k) K983987 Active Cleared 8 Jun 1999

• Amigo Escort 7.5, Model 760001 Phs

  Class II

  FDA 510(k) K092936 Active Cleared 4 Dec 2009

• Amigo Classic Fd

  Class II

  FDA 510(k) K101507 Active Cleared 30 Jul 2010

See all devices from Amigo Mobility Intl., Inc. →

• What is the AMIGO RT used for?

  The AMIGO RT is a power-operated vehicle designed for personal mobility. It features a streamlined design that allows it to fit into most vehicle trunks without disassembly and is suitable for use in various settings including narrow hallways due to its smaller wheel width.

• Is the AMIGO RT a single-use or reusable device?

  The AMIGO RT is a reusable device designed for long-term personal mobility use. It is a Class II medical device that can be used repeatedly by individuals who require motorized assistance for mobility.

• What is the regulatory status of the AMIGO RT?

  The AMIGO RT has FDA 510(k) clearance with number K981121, making it substantially equivalent to other legally marketed devices. It is classified as a Class II medical device under product code INI and is manufactured by Amigo Mobility Intl., Inc.

• How is the AMIGO RT supplied?

  The device is supplied as a complete motorized 3-wheeled vehicle ready for use. Its streamlined design allows it to fit into most vehicle trunks without requiring disassembly, making it convenient for transportation.