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Tisport

Active in EUDAMED

Registered as TiSport LLC in EUDAMED

Also registered as Tisport, LLC

United Statesfrom SRN EUDAMED FDA SRN US-MF-000046862 FEI 3002653226

Devices
7
Registrations
EUDAMEDFDA
FDA recalls
31 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

Catalogue7

Newest first, rows 1-7 of 7

  • Tilite Evo Ref K024055

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tipower Tr Rimpower And Tipower Tra Rimpower Ref K020639

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tilite Yg And Tilite Ygs Ref K023606

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cross Sport, Rigid Wheelchair Ref K990358 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tisport X And Tisport Xc Ref K990555

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tilite Aero X Ref K072311

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tipower Powerdrive And Rimpower X & Sx Ref K020539

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

EUDAMED SRN
US-MF-000046862
FDA FEI number
3002653226
EUDAMED status
Active
EUDAMED registered name
TiSport LLC
Registered address
2701, West Court Street, 99301, Pasco, United States
PRRC contact
Edgar Zamarron(public in EUDAMED)

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2021

    • 24 Sep 2021 Z-0264-2022 Class II Ongoing 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, verified, and released to the market. Distribution: US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA,…
      Full distribution text US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA, OR; OUS (Foreign): AUSTRALIA, CANADA, FRANCE, GERMANY, IRELAND, ITALY, UNITED KINGDOM, URUGUAY, NEW ZEALAND, IRELAND, SWEDEN
      Submission number: K990358

  • 2018

    • 11 Sep 2018 Z-2294-2019 Class II Terminated The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. Distribution: Distribution was nationwide, including Puerto Rico. There was also government distribution but no military distribution.…
      Full distribution text Distribution was nationwide, including Puerto Rico. There was also government distribution but no military distribution. Foreign distribution was made to Canada, Australia, Brazil, China, Italy, Saudi Arabia, Switzerland, United Kingdom, and Uruguay.
      Submission numbers: K023606, K990358, K072311

  • 2011

    • 5 Jul 2011 Z-3161-2011 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide Distribution Submission number: K990358

Frequently asked questions

How many devices does Tisport have in the registry?

The registry currently lists 7 devices for Tisport. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tisport's devices?

Among its 7 most recently registered devices, Tisport has devices listed in FDA 510(k) (7 devices).

What risk classes do Tisport's devices fall under?

Among its 7 most recently registered devices, the classes recorded for Tisport's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Tisport?

FDA recall records list 3 recalls initiated by Tisport, the most recent initiated on 24 Sep 2021. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Tisport in the registry?

The most recently registered devices listed for Tisport include TILITE EVO, TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER, TILITE YG AND TILITE YGS and CROSS SPORT, RIGID WHEELCHAIR.

Generated automatically from registry data and not verified by a human reviewer.