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Found 7 results
510(k) Data Aggregation
K Number
K072311Device Name
TILITE AERO X
Manufacturer
Date Cleared
2007-09-21
(35 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
TISPORT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.
Device Description
The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.
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K Number
K024055Device Name
TILITE EVO
Manufacturer
Date Cleared
2002-12-20
(11 days)
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
TISPORT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (manual, rigid wheelchair) is the same as the predicate device, the TiSport Cross-Sport (manual, rigid wheelchair) manufactured by TiSport, LLC. The intended use for the manual, rigid wheelchair is to provide mobility to physically persons. The manual wheelchair is intended for ongoing daily use.
This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:
- Amputee;
- Arthritis;
- Arthrogriposis;
- Cerebral Palsy;
- Geriatric conditions;
- Head injury or trauma;
- Hemiplegic;
- Multiple Sclerosis;
- Muscular Dystrophy;
- Paraplegic;
- Polio;
- Quadraplegic;
- Spina Bifida;
- Stoke/CVA;
- Tetraplegic; and
- Other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
Device Description
The TiLite Evo wheelchair is a rigid manual titanium wheelchair.
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K Number
K023606Device Name
TILITE YG AND TILITE YGS
Manufacturer
Date Cleared
2002-11-19
(22 days)
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
TISPORT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.
This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:
- Amputee;
- Arthritis:
- Arthrogriposis;
- Cerebral Palsy;
- geriatric conditions;
- head injury or trauma;
- hemiplegic;
- Multiple Sclerosis;
- Muscular Dystrophy;
- paraplegic;
- Polio:
- quadraplegic;
- Spina Bifida;
- Stoke/CVA;
- tetraplegic; and
- other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
Device Description
The TiLite YG and YGS model wheelchairs are rigid manual titanium wheelchairs.
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K Number
K020539Device Name
TIPOWER POWERDRIVE AND RIMPOWER X & SX
Manufacturer
Date Cleared
2002-06-20
(121 days)
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
TISPORT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
Device Description
The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.
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K Number
K020639Device Name
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
Manufacturer
Date Cleared
2002-06-20
(113 days)
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
TISPORT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis
Device Description
The TiPower TR Rim Power and TiPower TRA RimPower are rigid power/manual titanium wheelchairs.
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K Number
K990555Device Name
TISPORT X AND TISPORT XC
Manufacturer
Date Cleared
1999-03-22
(28 days)
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
TISPORT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury
Stoke/CVA
Post Polio Syndrome
Spina Bifada
Amputee
Multiple Scierosis
Arthrogriposis
Muscular Dystrophy
Lower and upper extremity paralysis
Device Description
The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.
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K Number
K990358Device Name
CROSS SPORT, RIGID WHEELCHAIR
Manufacturer
Date Cleared
1999-02-26
(21 days)
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
TISPORT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Post polio Spina Bifada Amputee
Device Description
The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.
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