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Mini Shopper

by Shoprider Intl., Inc.

510(k) K013927

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013927 Date28 Jan 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 19 Sep 2026

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

The Mini Shopper is a motorized three-wheeled vehicle, designed to provide optional mobility assistance for individuals with physical challenges. It falls under the classification of a mobility aid intended for indoor and outdoor use, supporting limited mobility users in navigating environments independently.

This device is supplied as a reusable, non-sterile product and is regulated under FDA 510(k) clearance (K013927) as a Class II medical device under regulation number 890.3800. It is intended for use in clinical and home settings, with no specific MRI safety restrictions noted. The device is distributed under product code INI and requires proper maintenance to ensure safe operation.

Other devices from Shoprider Intl., Inc.

  • Sovereign

    Class II

  • SNAZZY2

    Class II

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the Mini Shopper designed for use in both indoor and outdoor environments, and how does this affect its maintenance requirements?

    Yes, the Mini Shopper is explicitly designed for both indoor and outdoor use to assist individuals with limited mobility. Since it operates in varied environments, regular maintenance is essential to ensure safe and reliable operation, particularly to address potential wear from outdoor surfaces or exposure to elements.

  • What types of settings is the Mini Shopper approved for, and does it have any specific safety restrictions for use with medical imaging?

    The Mini Shopper is approved for use in both clinical and home settings. There are no specific MRI safety restrictions mentioned in the documentation, meaning it can be used in areas where MRI machines are present without known interference concerns.

  • How is the Mini Shopper supplied, and what does this mean for its reusability and cleaning requirements?

    The Mini Shopper is supplied as a reusable, non-sterile product. This means it is intended for multiple uses by the same or different individuals, but it must be cleaned and maintained according to manufacturer guidelines to ensure hygiene and functionality.

  • Are there different models or sizes available for the Mini Shopper, and how can I identify which one is best suited for a specific user?

    The Mini Shopper comes in multiple models, as indicated by the extensive list of registration numbers (e.g., 3033905189, 3012604975, etc.). While specific size or model details aren’t provided in the data, these variations likely cater to different user needs such as weight capacity, maneuverability, or seating adjustments. Consulting the manufacturer or a healthcare professional can help determine the best fit for a user’s requirements.