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510(k) Data Aggregation
K Number
K152021Device Name
Pure Tilt
Manufacturer
Date Cleared
2016-03-31
(254 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Proactive Comfort, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features:
- A tilting seat with adjusting capability up to 45°;
- User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring piston;
- Hinged, non-detachable armrests that swing upward and toward the back to facilitate transfer of a subject into or out of the wheelchair;
- Built-in housing for compatible transfer board;
- Mechanical armrest locks that secure the armrests to be used safely as handles for lifting the wheelchair with the user in it;
- Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
- Two 6" diameter front casters that swivel for easy maneuvering;
- Adjustable seat-to-floor height (2 Settings: 19" and 17");
- Angle-adjustable leg-rest assembly with the following features:
- Foot platform that swings upward to facilitate stowage .
- Telescoping adjustable height .
- User-operated mechanism to adjust leg-position angle, which is assisted by mechanical spring piston;
- Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
- Headrest with adjustable vertical position.
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