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For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back. The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.

The Contour Next USB blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The system consists of a Contour Next USB blood glucose meter, Contour Next test strips and Contour Next control solutions. The Contour Next USB blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The Contour Next USB blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour Next Test Strips are for use with the Contour Next USB blood glucose monitoring system for the quantitative measurement of glucose in whole blood.

The Contour Next USB Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next USB Blood Glucose Monitoring System. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

Contour Next Control Solution is used as a quality control check to assure the customer that their Bayer Contour Next blood glucose monitoring system is reading accurately. The control solution has a very controlled amount of glucose in it. The bottles of Contour Next test strips have a range of acceptable values on every bottle that is used to compare the result obtained when the control solution is applied to the test strip. When the reading from the control solution is within the range on the bottle, the system has been quality control checked and shown to be accurate. If the reading from the control solution is outside the stated range, then the customer is instructed by the user guide to not use the system until trouble-shooting can be done and/or customer service is called for help. The Solution is a prescribed amount of glucose in water and includes a buffer, red dye, and a thickening agent. The control solution comes in a 2.5mL plastic bottle with an applicator tip. It comes in two glucose levels, Level 1 (about 45mg/dL) and Level 2 (about 125mg/dL).

The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.

The Contour NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The Contour NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Contour NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The Contour NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The Contour NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a blood glucose meter, dry test strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System also contains radio frequency (RF) functions for sending BGM results to compatible Medtronic MiniMed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic MiniMed insulin pumps to Medtronic's MiniMed PC-based data management software.

The CONTOUR®NEXT Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR®NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check. The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR® NEXT Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.

The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR® NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Contour® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood. The Contour® NEXT Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are working properly. Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Baver's Contour and Breeze families of meters.

The Contour NEXT USB Blood Glucose Monitoring System consists of a small handheld blood glucose meter that is substantially equivalent in look and feel to the predicate system. Contour Next Wireless Blood Glucose Meter, (K110894). The system also consists of dry reagent test strips used for the measurement of glucose in capillary whole blood and includes liquid controls to check the performance of the system. The chemical principle of the system is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample.

The CONTOUR® LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip only. CONTOUR® test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps through use of radio frequency communication. The CONTOUR® LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The CONTOUR LINK Wireless Blood Glucose Monitoring System features the CONTOUR LINK Wireless Blood Glucose Monitor and the currently marketed CONTOUR Blood Glucose Test Strips, among other components (e.g., lancing device, lancets and control solution)

The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a Contour NEXT LINK Wireless Blood Glucose Meter, CONTOUR® NEXT Test Strips and CONTOUR® NEXT Control Solutions. CONTOUR® NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® NEXT Control Solutions are aqueous glucose solutions intended for use in selftesting by people with diabetes as a quality control check. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit dlucose values to Medtronic MiniMed Paradigm Insulin pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm® REAL-TIME Insulin Pumps or Guardian REAL-TIME Monitor and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a small handheld electronic device is substantially equivalent in look and feel to the Contour® USB predicate system (K091820). The System also contains dry reagent strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System is intended to transmit blood glucose results to compatible Medtronic Minimed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic Minimed insulin pumps to Medtronic's Minimed PC based data management software.