The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Power Wheelchair Or Hvr-200 By Hoveround.
| Device ID | K954131 |
| 510k Number | K954131 |
| Device Name: | HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND |
| Classification | Wheelchair, Powered |
| Applicant | HOVEROUND CORP. 8135 25TH CT. EAST Sarasota, FL 34243 |
| Contact | Thomas E Kruse |
| Correspondent | Thomas E Kruse HOVEROUND CORP. 8135 25TH CT. EAST 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 | 1995-09-01 |
| Decision Date | 1996-06-06 |