Hoveround Corp.
Sarasota, FL, US
Hoveround Corp. appears in FDA device records in Sarasota, FL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Hoveround Corp. between 1994 and 2013. The busiest year on record is 2004, with 4. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1996 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 4 |
| 2009 | 1 |
| 2010 | 3 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122741 | HOVEROUND TEKNIQUE | ITI | Substantially Equivalent | |
| K122707 | HOVERROUND TEKNIQUE | ITI | Substantially Equivalent | |
| K100527 | HOVEROUND TEKNIQUE, MODEL HD-6 | ITI | Substantially Equivalent | |
| K100350 | HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT | ITI | Substantially Equivalent | |
| K093946 | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | ILK | Substantially Equivalent | |
| K090108 | HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K043069 | HOVEROUND E100 POWER CHAIR | ITI | Substantially Equivalent | |
| K042920 | HOVEROUND SE-3 POWERCHAIR | ITI | Substantially Equivalent | |
| K042545 | HOVEROUND MPV-5 POWERCHAIR | ITI | Substantially Equivalent | |
| K042033 | HOVEROUND POWER WHEELCHAIR, MODEL HD700 | ITI | Substantially Equivalent | |
| K022993 | HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS | ITI | Substantially Equivalent | |
| K021136 | TEKNIQUE-HOVEROUND POWER WHEEL CHAIR | ITI | Substantially Equivalent | |
| K010075 | TEKNIQUE | ITI | Substantially Equivalent | |
| K991132 | ACTIVA | INI | Substantially Equivalent | |
| K954131 | HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND | ITI | Substantially Equivalent | |
| K935410 | HOVEROUND MPV | ITI | Substantially Equivalent for Some Indications | |
| K932329 | HOVEROUND POWER CHAIR | ITI | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain