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The Game Ready system is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulate kneading and stroking of tissues using an inflatable wrap. The Game Ready system is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, Large, Right (590432-04); Game Ready Shoulder Wrap, Medium, Left (590424-04); Game Ready Shoulder Wrap, Large, Left (590434-04); Game Ready Hip/Groin Wrap, Right (590602-04); Game Ready Hip/Groin Wrap, Left (590604-04); Game Ready Straight Knee Wrap (590100-04); Game Articulated Knee Wrap (590160-04); Game Ready Ankle Wrap, Large (590330-04); Game Ready Ankle Wrap, Extra Large (590340-04)

The CORGRIP* SR Nasogastric/Nasointestinal (NG/N) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal of displacement of the tubes for adult patients.

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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only AVANOS* and Diros RF Probes and accessories, such as Cooled / Standard RF Pain Management Probes, Cannulas, and Introducers. Use of the CRG System is limited to the indications cleared under these devices and accessories.

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block. The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following: - COOLIEF* Cooled Radiofrequency Probe Advanced - COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ● - COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ● The modifications to the subject device are specific to the probe and fluid tubing kit. The subject probe and fluid tubing kit are also included in the COOLIEF*SINERGY* Cooled Radiofrequency Kit Advanced. The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.

COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.

CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally-positioned receiver unit. The received signals are input to the attached All-In-One Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The CORTRAK*2 Equilateral EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be use in clinical environment.