The following data is part of a premarket notification filed by Hoveround Corp. with the FDA for Hoveround Power Chair.
Device ID | K932329 |
510k Number | K932329 |
Device Name: | HOVEROUND POWER CHAIR |
Classification | Wheelchair, Powered |
Applicant | HOVEROUND CORP. 1748 INDEPENDENCE BLVD. SUITE B1 Sarasota, FL 34234 |
Contact | Donald L Shapiro |
Correspondent | Donald L Shapiro HOVEROUND CORP. 1748 INDEPENDENCE BLVD. SUITE B1 Sarasota, FL 34234 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-13 |
Decision Date | 1994-03-28 |