Data / Medical devices / United States / Tisport, LLC
Tisport, LLC: FDA-registered device maker in Pasco, WA, United States, 4 510(k) clearances
Tisport, LLC is registered with the FDA (registration 3032618) in Pasco, WA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 21, 2007. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032618
- FEI number
- 3002653226
- Address
- 2701 W Court St, Pasco, WA, United States, 99301
- Owner or operator
- TISPORT, LLC (9036395)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 25, 1999
- Registered through
- 2026
- Brand names listed
- TiLite 2GX, TiLite Aero T, TiLite Aero X, TiLite Aero Z, TiLite CR1, TiLite Pilot, TiLite TR, TiLite TRA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Wheelchair | KNN | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2007 | K072311 | TILITE AERO X | IOR | Substantially Equivalent | Tisport, LLC | accessdata.fda.gov |
| November 19, 2002 | K023606 | TILITE YG AND TILITE YGS | IOR | Substantially Equivalent | Tisport | accessdata.fda.gov |
| March 22, 1999 | K990555 | TISPORT X AND TISPORT XC | IOR | Substantially Equivalent | Tisport | accessdata.fda.gov |
| February 26, 1999 | K990358 | CROSS SPORT, RIGID WHEELCHAIR | IOR | Substantially Equivalent | Tisport | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2021 | 88718 | Class II | Ongoing | Permobil TiLite, Models: Aero Z, and ZRA | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verif | accessdata.fda.gov |
| September 11, 2018 | 83360 | Class II | Terminated | TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is p | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. | accessdata.fda.gov |
| July 5, 2011 | 59305 | Not yet classified | Terminated | TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for | The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off. | accessdata.fda.gov |
Compare with other makers
Updated September 21, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.