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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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