Tisport: FDA clearances and approvals
Tisport has 7 FDA 510(k) clearances (first 1999, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time: 28 days. openFDA lists 3 product recalls by a recalling firm named Tisport.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 5 | 5 |
| ITI | Wheelchair, Powered | 2 | 2 |
Review panels
Most recent Tisport 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072311 | TILITE AERO X | IOR | 2007-09-21 | 35 |
| K024055 | TILITE EVO | IOR | 2002-12-20 | 11 |
| K023606 | TILITE YG AND TILITE YGS | IOR | 2002-11-19 | 22 |
| K020639 | TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER | ITI | 2002-06-20 | 113 |
| K020539 | TIPOWER POWERDRIVE AND RIMPOWER X & SX | ITI | 2002-06-20 | 121 |
| K990555 | TISPORT X AND TISPORT XC | IOR | 1999-03-22 | 28 |
| K990358 | CROSS SPORT, RIGID WHEELCHAIR | IOR | 1999-02-26 | 21 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-09-24.
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 Tisport have?
Tisport has 7 FDA 510(k) clearances (first 1999, latest 2007), across 2 product codes in 1 review panel.
How long does FDA take to clear Tisport's 510(k)s?
The median time from FDA receipt to decision across Tisport's cleared 510(k)s is 28 days.
What devices does Tisport make?
Its most frequent FDA product codes are IOR (Wheelchair, Mechanical, 5); ITI (Wheelchair, Powered, 2).
Has Tisport had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Tisport; the most recent began 2021-09-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Tisport clearances with predicates and recalls
- Run predicate analysis for product code IOR, Tisport'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.