The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Hoverglide Model Hoverglide Mk-2.
| Device ID | K093946 |
| 510k Number | K093946 |
| Device Name: | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 |
| Classification | Transport, Patient, Powered |
| Applicant | HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
| Contact | Tony Digiovanni |
| Correspondent | Tony Digiovanni HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
| Product Code | ILK |
| CFR Regulation Number | 890.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-03-22 |