Alpha Super Kart

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

510(k) Number

K853766 ↗

FDA Product Code

INI

Device Class

Class II

Regulation

21 CFR Part 890.3800

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Alpha 4 X 4

  Class II

  FDA 510(k) K841912 Active Cleared 23 May 1984

• Alpha Tri-Kart

  Class II

  FDA 510(k) K841919 Active Cleared 23 May 1984

• Alpha Mallard

  Class II

  FDA 510(k) K893248 Active Cleared 26 May 1989

• Alpha Push Kart

  Class I

  FDA 510(k) K841911 Active Cleared 23 May 1984

• Alpha Condor

  Class II

  FDA 510(k) K893429 Active Cleared 12 Jun 1989

• Mac-Multi-Adjustable Chair

  Class II

  FDA 510(k) K841920 Active Cleared 23 May 1984

See all devices from Alpha Unlimited, Inc. →

• What is the Alpha Super Kart intended for?

  The Alpha Super Kart is intended for use in physical medicine settings as a motorized three-wheeled vehicle, based on its classification under the Physical Medicine specialty and its FDA 510(k) clearance as substantially equivalent to a predicate device.

• Is the Alpha Super Kart sterile or single-use?

  The Alpha Super Kart is a reusable device with no stated sterility requirements, as it is supplied as a finished product for repeated use in physical medicine environments without indication of sterilization or disposability.

• How is the Alpha Super Kart supplied and what is its regulatory status?

  The device is supplied as a finished product and received FDA 510(k) clearance (K853766) as substantially equivalent to a predicate device, with a traditional clearance pathway and product code INI under regulation number 890.3800.