Product Classification / EMDN Category
FDA Product Code: PCC
Directory of devices assigned to product classification code PCC.
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The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Manufacturer: WAT Medical Technology Inc.
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An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
Manufacturer: NEUROLIEF LTD
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A cloud-based Patient Management Interface (PMI Physician Interface and cloud platform)
Manufacturer: NEUROLIEF LTD
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Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal (Supraorbital and Supratrochlear) and Occipital nerves to treat headaches.
Manufacturer: NEUROLIEF LTD
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Transcutaneous Electrical Nerve Stimulator for Migraine Headaches
Manufacturer: Hinge Health, Inc.
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Indications for Use:CEFALY Connected is indicated to be used for:Acute treatment of migraine with or without aura in patients 18 years of age or older.Prophylactic treatment of migraine in patients 18 years of age or older.
Manufacturer: Cefaly Technology SPRL
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Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
Manufacturer: Cefaly Technology SPRL
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CEFALY Connected is indicated to be used for:Acute treatment of migraine with or without aura in patients 18 years of age or older.Preventative treatment of migraine in patients 18 years of age or older.
Manufacturer: Cefaly Technology SPRL
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CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use.CEFALY Enhanced is indicated to be used for:Acute treatment of migraine with or without aura in patients 18 years of age or older.Preventative treatment of migraine in patients 18 years of age or older.
Manufacturer: Cefaly Technology SPRL
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The Cefaly Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.
Manufacturer: Cefaly Technology SPRL
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The Cefaly Dual device is indicated for:- The acute treatment of migraine with or without aura in patients 18 years of age or older.- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Manufacturer: Cefaly Technology SPRL
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The Cefaly Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.
Manufacturer: Cefaly Technology SPRL
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Set Cefaly :- Instruction manual- Cefaly device- Cefaly electrode- Storage box- Power adapter + cable
Manufacturer: Cefaly Technology SPRL
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