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Flyer

by Motion Dynamics

510(k) K915416

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 NumberK915416 Date3 Aug 1992ClearedStatusActive

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  • Withdrawn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)

Full name
Fymco Flyer
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 Flyer is a motorized three-wheeled vehicle designed for physical medicine applications. Classified as a motorized vehicle under FDA nomenclature, it is intended for use in therapeutic settings to assist patients with mobility support.

Supplied as a reusable device, the Flyer is regulated under FDA 510(k) clearance (K915416) and falls under device class II. It is intended for use in clinical or rehabilitative environments, with no specified sterility requirements. The device is authorized for distribution in the United States and adheres to regulatory standards outlined in 890.3800.

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.

  • What is the primary use case for the FYMCO FLYER in clinical settings?

    The FYMCO FLYER is designed specifically for physical medicine applications to provide mobility support for patients in therapeutic or rehabilitative environments. It is a motorized three-wheeled vehicle intended to assist patients who require additional stability or movement assistance during physical therapy or recovery.

  • Is the FYMCO FLYER a single-use or reusable device?

    The FYMCO FLYER is supplied as a reusable device, meaning it is intended to be used repeatedly across multiple patients or sessions, provided it is properly cleaned and maintained according to facility protocols. There are no specified sterility requirements for this device.

  • What regulatory pathway was followed for the FDA clearance of the FYMCO FLYER?

    The FYMCO FLYER received FDA clearance through a 510(k) submission, classified as Traditional, and was determined to be Substantially Equivalent to a predicate device. The device falls under Class II regulatory classification and was reviewed by the Physical Medicine (PM) Advisory Committee. The clearance number is K915416, and it adheres to regulatory standards outlined under 890.3800.

  • Are there multiple models or sizes available for the FYMCO FLYER?

    Yes, the FYMCO FLYER comes in multiple configurations, as indicated by the OpenFDA registration numbers (e.g., 3033905189, 3012604975, etc.), which suggest variations in design or specifications. These likely correspond to different models or customizable features to accommodate varying patient needs in physical medicine settings.