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Hoveround Hoverglide Model Hoverglide MK-2

by Hoveround Corp.

510(k) K093946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093946 Date22 Mar 2010ClearedStatusActive

Official records

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  • Withdrawn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
ILK
Device class
Class II
Regulation
21 CFR Part 890.5150
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is a powered patient transport device, as defined in the device name and openfda fields. It is substantially equivalent to a predicate device and cleared under the traditional 510(k) pathway.

It is manufactured by Hoveround Corp. and authorized under FDA 510(k) clearance K093946. The device is classified as a Class II medical device with product code ILK and regulation number 890.5150, and is intended for use in physical medicine settings.

Similar devices

Other devices filed under FDA product code ILK (Transport, Patient, Powered).

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