The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Mpv-5 Powerchair.
Device ID | K042545 |
510k Number | K042545 |
Device Name: | HOVEROUND MPV-5 POWERCHAIR |
Classification | Wheelchair, 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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-20 |
Decision Date | 2004-10-21 |