DEROYAL INDUSTRIES, INC. 35-401105 DeRoyal

TIDI Positioning Aid Kits Kit, Various Sizes 7 per Set

ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

KIT, SMALL, "A". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387)

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

K-WIRE TROCAR POINT BOTH ENDS .062 X 4

Neurofeedback Software

K-WIRE Trocar POINT BOTH ENDS .035 x 4

CATALYST 4 MANUAL WHEELCHAIR

TIDI Positioning Aid Kits Kit, Various Sizes 7 per Set

ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

KIT, SMALL, "A". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387)