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To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk.

Navigator I was designed to assist individuals with limited mobility to maintain an active lifestyle. Its manual steering, high-torque four brush motor with rear wheel drive, large diameter (16") front wheels, high ground clearance (5.4"), full circle turning radius (27.5"), side to side anti-tip resistance, and curb climbing (5.5") ability make it a versatile vehicle equally adept in the shopping mall, on firm surface wilderness trails, or in the close quarters of a restaurant or home kitchen. Navigator I is a blended hybrid drawine elements from both scooters and wheelchairs, to meet desired features requested by long term scooter users. It does this while still maintaining the three-wheel scooter configuration with manual steering and anti-tip wheels adjacent to the single steering wheel. Navigator I is an clectronically controlled motorized 3-wheeled vehicle employing a rear single wheel remotely steerable motor drive system (11.5" tire). It employs a 24 Volt DC permanent magnet motor powered by two 12 Volt scaled lead acid deep cycle batteries. The rigid Front Frame Assembly holds the two batteries, mounts the two front 16" diameter wheels, the two front hand controlled parking brakes, the swing up front foot rests, the electronic motor controller, and the steering arm with handle incorporating the 6-position variable speed-control. The Rear Frame Assembly is made up of the rear motor drive, the swing out Anti-tip wheels, the rear bearing block assembly and pivot wheel assembly. The Front and Rear Frame Assemblies are connected together by two semi-rigid Torsional Elements™ (relatively rigid to a vertical load, but allowing limited rotation), which also support the scat block mounting assembly. The Torsional Elements™ allow limited twist (similar to the Articulation Beam in the Pride Jazzy, K945936) to occur between the Front and Rear Frame Assemblics up to 5° of rotation, at which point one Anti-tip wheel with the ground. This greatly enhances side to side stability when driving Navigator I over rough terrain, since Navigator I is smothly transformed from three wheels to four wheels with ground contact on all four wheels.

Dynamic Healthcare Technologies' PACSPlus, version 2.0, is indicated for use by radiology professionals to capture, store, distribute and display radiological images and information over local and Wide Area Networks. The only editing of the images is via the wavelet lossy compression feature, using the Pegasus PICtools ™ Medical Compression toolkit, a 510(k)-cleared medical device product (K#982146).

"Dynamic PACSPlus Version 2.0 is an information-enabled PACS (Picture Archiving and Communication System) that integrates all information from the RIS with images from PACS. Image capture is available from most imaging modalities using DICOM interfaces and selected non-DICOM interfaces. PACSPlus InfoBroker Servers are used as gateways that capture the DICOM images, reconcile the DICOM information with order information from the RIS, and provide access to additional exam and patient information including results. The PACSPlus Image and Information Server stores, indexes, and distributes images and information. Images can be viewed through the web-based Dynamic WebSight viewer. Exams can be accessed by patient identifiers, location, or by physician. The entire imaging exam history is shown (film and digital) to allow the viewer to select any results or available digital images. " (source: Product Fact Sheet, Dynamic Healthcare Technologies, Inc.)

To remove lice eggs from hair.

The product is a system consisting of two components: (a) a glass reinforced nylon fine tooth nit comb; and (b) an enzyme gel cleansing agent intended to be used together with the comb to facilitate the combing out of lice eggs (nits) from the hair. The combing aid gel is a non-toxic water based vegetable derived enzyme composition. The product is substantially equivalent to other nit removal products, including the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574). The technological characteristics of the nit comb component are the same as other marketed products, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth (0.1 to 0.2 mm). Spacing between the teeth of the comb component is 0.2 mm. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm).

For lice egg detection and removal

The product is a nit comb intended for use in detecting and removing lice eggs from the hair. It is constructed of closely spaced stainless steel teeth imbedded in a high density polyethylene handle. The points and edges of the teeth are rounded so as not to cut or damage hair or scalp. The comb can be cleaned with soap and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (K822574). The technological characteristics of the Clear Special Nit Comb are the same as other marketed nit combs, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm). The spacing between the teeth of the Clear Special Nit Comb is 200 microns (0.2mm).