The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Teknique Gt Power Wheelchair, Model# Teknique Gt.
| Device ID | K100350 |
| 510k Number | K100350 |
| Device Name: | HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT |
| Classification | Wheelchair, Powered |
| Applicant | HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
| Contact | Tony Giovanni |
| Correspondent | Tony Giovanni HOVEROUND CORP. 2151 WHITFIELD INDUSTRIAL WAY Sarasota, FL 34243 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-03-22 |