Hoveround Corp.: FDA clearances and approvals
Hoveround Corp. has 17 FDA 510(k) clearances (first 1994, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time: 63 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 244 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 15 | 15 |
| ILK | Transport, Patient, Powered | 1 | 1 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
- Physical Medicine (17)
Most recent Hoveround Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122741 | HOVEROUND TEKNIQUE | ITI | 2013-05-07 | 242 |
| K122707 | HOVERROUND TEKNIQUE | ITI | 2013-05-07 | 245 |
| K100527 | HOVEROUND TEKNIQUE, MODEL HD-6 | ITI | 2010-03-26 | 30 |
| K100350 | HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT | ITI | 2010-03-22 | 38 |
| K093946 | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | ILK | 2010-03-22 | 89 |
| K090108 | HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR | ITI | 2009-03-19 | 63 |
| K043069 | HOVEROUND E100 POWER CHAIR | ITI | 2004-12-03 | 25 |
| K042920 | HOVEROUND SE-3 POWERCHAIR | ITI | 2004-12-03 | 42 |
| K042545 | HOVEROUND MPV-5 POWERCHAIR | ITI | 2004-10-21 | 31 |
| K042033 | HOVEROUND POWER WHEELCHAIR, MODEL HD700 | ITI | 2004-09-29 | 62 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hoveround Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hoveround Corp. have?
Hoveround Corp. has 17 FDA 510(k) clearances (first 1994, latest 2013), across 3 product codes in 1 review panel.
How long does FDA take to clear Hoveround Corp.'s 510(k)s?
The median time from FDA receipt to decision across Hoveround Corp.'s cleared 510(k)s is 63 days.
What devices does Hoveround Corp. make?
Its most frequent FDA product codes are ITI (Wheelchair, Powered, 15); ILK (Transport, Patient, Powered, 1); INI (Vehicle, Motorized 3-Wheeled, 1).
Has Hoveround Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hoveround Corp. Related entities may recall under other names.
Next steps
- See all 17 Hoveround Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Hoveround Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.