510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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TiSport, LLC

Pasco, WA, US

TISPORT, LLC appears in FDA device records in Pasco, WA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for TiSport, LLC between 1999 and 2007. The busiest year on record is 2002, with 4. The most recent is 2007, with 1.

Clearances by year, as a table
510(k) clearance decisions for TiSport, LLC, by decision year
YearClearances
19992
20024
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K072311TILITE AERO XIORSubstantially Equivalent
K024055TILITE EVOIORSubstantially Equivalent
K023606TILITE YG AND TILITE YGSIORSubstantially Equivalent
K020639TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWERITISubstantially Equivalent
K020539TIPOWER POWERDRIVE AND RIMPOWER X & SXITISubstantially Equivalent
K990555TISPORT X AND TISPORT XCIORSubstantially Equivalent
K990358CROSS SPORT, RIGID WHEELCHAIRIORSubstantially Equivalent

Registered establishments

FDA registered establishments for TiSport, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30326183002653226TISPORT, LLC2701 W Court St, Pasco, WA 99301 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0264-2022Permobil TiLite, Models: Aero Z, and ZRASome 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.Class IIOpen, Classified
Z-2294-2019TiLite 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 part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.Class IITerminated
Z-3161-2011TiLite 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 physically impaired individuals.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.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain