NORAV MEDICAL LTD. 1200HR-K-00-U-B10-04 Norav 1200 Series PC-ECG

Invacare Absolute Cushion

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.

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.

PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with AHA type labelling.

#1200 IV Start KitContents: (1) IV Dressing, (1) Tourniquet Latex, (2) Alcohol Prep Pad

The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.