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LA Personal Scooter

by Assembled Products Corp. 510(k)

Active United States

510(k) K000869

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000869 Date19 Jul 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
INI
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LA Personal Scooter is a motorized three-wheeled vehicle designed for mobility assistance. Classified as a Class II device under FDA regulation 890.3800, it is intended for use by individuals requiring enhanced mobility, particularly in physical medicine settings. Its three-wheeled configuration provides stability and maneuverability for indoor and outdoor environments.

Supplied as a reusable device, the LA Personal Scooter is intended for use in clinical and home settings. It does not require sterilization but must be maintained according to manufacturer guidelines to ensure safe operation. The device carries an FDA 510(k) clearance (K000869) under the Traditional 510(k) Review process, with a decision of Substantially Equivalent (SESE) issued on July 19, 2000. Multiple registration numbers and FEI numbers are associated with its regulatory filing.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LA Personal Scooter designed for?

    The LA Personal Scooter is a motorized three-wheeled vehicle intended for individuals requiring enhanced mobility, particularly in physical medicine settings. Its three-wheeled design provides stability and ease of maneuvering in both indoor and outdoor environments, making it suitable for clinical and home use.

  • Is the LA Personal Scooter reusable or single-use?

    The LA Personal Scooter is supplied as a reusable device. While it does not require sterilization, it must be maintained according to the manufacturer’s guidelines to ensure safe and reliable operation over time.

  • Does the LA Personal Scooter require sterilization?

    No, the LA Personal Scooter does not require sterilization. However, regular maintenance as outlined by the manufacturer is essential to preserve its functionality, safety, and longevity for repeated use.

  • What regulatory approval does the LA Personal Scooter hold?

    The LA Personal Scooter holds an FDA 510(k) clearance (K000869) under the Traditional 510(k) Review process, classified as Substantially Equivalent (SESE) and filed under the Physical Medicine advisory committee. It is categorized as a Class II device under FDA regulation 890.3800.

  • How many registration numbers are associated with the LA Personal Scooter?

    The LA Personal Scooter is linked to multiple registration numbers and FEI numbers, totaling over 60 unique identifiers. These are used for regulatory tracking and compliance purposes, ensuring proper documentation across various submissions and filings.