Anodyne therapy products

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(a.k.a. Anodyne Therapy System ) _ _ _ _ _ _ _ _ Method of Topical Topical Topical administration Treatment areas 10cm2 Leg, foot, arm, neck Lower leg, foot, adjustable location Number of Not specified in product 4-8 therapy pads Four zones zones labeling

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August 12th,2020

Craig H. Turtzo, President Restorative Products, Inc ...

The promotion of the Anodyne Therapy System for these uses indicates a major modification in the intended use of the device and requires a new premarket submission. 21 CFR 807.81(a)(3)(ii). Because you do not have marketing clearance from the FDA for these new intended uses, marketing the Anodyne Therapy

August 12th,2020

Model 120 for Professional 2016 - Anodyne Therapy

To send a unit to Anodyne Therapy, LLC for repair, you must fi rst call 1-800-521-6664 and obtain a return authorization (RA). The following information must be supplied to Anodyne Therapy, LLC before an RA number can be issued: 1) User name and address 2) Device serial number 3) A …

August 12th,2020

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(a.k.a. Anodyne Therapy System ) _ _ _ _ _ _ _ _ Method of Topical Topical Topical administration Treatment areas 10cm2 Leg, foot, arm, neck Lower leg, foot, adjustable location Number of Not specified in product 4-8 therapy pads Four zones zones labeling

August 12th,2020

Anodyne Therapy Consumer System

Anodyne® Therapy Systems received clearance from the US FDA in 1994 and are compliant to the ISO 13485 Inter-national Standard. Review this manual in its entirety prior to using this system and contact Anodyne Therapy, LLC at 1-800-521-6664 with any questions, comments or concerns. 23 INDEX Cleaning, 15 Contraindications, 4 Control Unit, 5, 7 ...

August 12th,2020

BARTON COUNTY INFORMATION & RESOURCES

Sep 08, 2018 · Anodyne Therapy, Wound Care, and Glucose Monitoring. Almost Home GB Hospice 1919 VanBuren Great Bend, KS : 620 -617 -1634 Quality Care in a loving, home -like environment. ElderCare, Inc. 1819 11th St Great Bend, KS 67530 . 620 -792 -1241 /877 -792 -5942 (Friendship Meals : 800 -530 -5068) Gentiva Hospice 1117 N. Washington

August 12th,2020

HealthSouth’s Products and Services

The Anodyne Therapy System is a non-invasive, drug-free device that delivers Monochromatic Infrared Energy (MIRE) through infrared light-emitting diodes that are mounted in flexible therapy pads. When the therapy pads are placed in direct contact with the skin, the invisible infrared light is absorbed by cells in the body and blood vessels begin

August 12th,2020

Questions about Anodyne Therapy? - Touro

As part of your treatment plan, you will be receiving treatment with an extraordinary technology called Anodyne Therapy that has been delivering amazing health benefits for more than 20 years. Based on discoveries that led to the award of the Nobel Prize in Medicine, Anodyne delivers a …

August 12th,2020

Medical Coverage Policy

The Anodyne Professional Therapy System is a MIRE device that received marketing clearance from the U.S. Food and Drug Administration (FDA) in 1994 through the 510(k) process. A device specifically for home use is also available. The labeled indication is for “increasing circulation and decreasing pain.” MIRE devices have

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