WebSep 29, 2024 · Trade/Device Name: Cefaly Dual . Regulation Number: 21 CFR 882.5891 . Regulation Name: Transcutaneous Electrical Nerve Stimulator to Treat Headache . ... Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further … WebOct 8, 2014 · The correct code for Cefaly® is: A9270 – Noncovered item or service. For questions about correct coding, contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form .
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WebCRF 882.5891, Product Code PCC) Device Class: Class II 5.3. Substantial equivalency Substantial Equivalency is claimed against the following legally marketed device: Cefaly® (510(k) number K160237). 5.4. Description of the device The Cefaly® Acute device is a supraorbital transcutaneous electrical nerve stimulator device to Web11 rows · Durable Medical Equipment Coding System (DMECS) HCPCS Details & Fees. … rapoo 6010b
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WebJan 18, 2024 · Cefaly is a device used for the treatment and prevention of migraines. It is worn externally on the forehead, and it delivers electrical impulses that stimulate nerves that are believed to play a role in migraines. This device is approved by the U.S. Food and Drug Administration (FDA) for treatment of acute migraines and for migraine prevention ... WebNov 25, 2024 · Cefaly Dual Enhanced is a drug-free alternative treatment for migraine. The device sticks to a person’s forehead and emits electrical impulses that aim to ease and … WebIf coverage for an in-home electrical stimulation device is available, the following conditions of coverage apply. Neuromuscular Electrical Stimulation (NMES) ... (HCPCS Code … dromana removals \u0026 storage