510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093946Substantially Equivalent

Hoveround Hoverglide Model Hoverglide Mk-2

Hoveround Corp., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093946 is the FDA 510(k) clearance record for HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2, a class II device, cleared for Hoveround Corp. on under FDA product code ILK (Transport, Patient, Powered). FDA's definition for product code ILK reads: "A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g...". FDA records list 17 510(k) clearances for Hoveround Corp., from to . As of , FDA records show no recalls naming K093946.

Clearance record

Decision date
Received
(89 days to decision)
Product code
ILK Transport, Patient, Powered
Regulation
21 CFR 890.5150
Device class
Class II
Review panel
Physical Medicine
Applicant
Hoveround Corp. 2151 Whitfield Industrial Way, Sarasota FL
510(k) summary
Statement
Third party review
No

Clearances, product code ILK

Trailing 12 months

FDA records hold no clearances under product code ILK in the trailing twelve months.

FDA records show no clearances under product code ILK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260