510(k) Report

FDA applicant

Tisport

Kennewick, WA7 decisions1999–20073 recalls

FDA records 7 decisions for Tisport (Kennewick, WA) from 1999 to 2007: 7 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and ITI (Wheelchair, Powered). Its devices cite 7 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Tisport, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Tisport’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2021

2011: 12018: 12021: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tisport by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tisport’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IORWheelchair, Mechanical5decisions
  • ITIWheelchair, Powered2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990358Cross Sport, Rigid WheelchairTisport · 19991cites it

What has FDA decided for it lately?

  • K072311Tilite Aero XTisport, LLC · 20071 recall
  • K024055Tilite EvoTisport, LLC · 2002
  • K023606Tilite YG and Tilite YgsTisport · 20021 recall
  • K020639Tipower TR Rimpower and Tipower Tra RimpowerTisport · 2002
  • K020539Tipower Powerdrive and Rimpower X & SXTisport · 2002
  • K990555Tisport X and Tisport XCTisport · 1999
  • K990358Cross Sport, Rigid WheelchairTisport · 19993 recalls

All 5 as Tisport →All 2 as Tisport, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K990358Permobil TiLite, Models: Aero Z, and ZRASep 24, 2021Class II
  • K023606TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and…Sep 11, 2018Class II
  • K990358TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name…Jul 5, 2011