| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05425018850310 | 11302 | Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes) | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® | |
| 2 | 05425018850303 | 11301 | CEFALY Enhanced Electrode Kit .3 electrodes | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® | |
| 3 | 05425018850273 | CEFALY DUAL Enhanced | 10601 | Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use:CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use.CEFALY DUAL Enhanced is indicated to be used for:The acute treatment of migraine with or without aura in patients 18 years of age or older.The preventative treatment of episodic migraine in patients 18 years of age or older. | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® |
| 4 | 05425018850266 | Prevent | 10230 | The Cefaly® Prevent device is indicated for the prophylactic treatment of episod The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults. | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® |
| 5 | 05425018850242 | Acute | 10405 | The Cefaly® Acute device is indicated for the acute treatment of migraine with o The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® |
| 6 | 05425018850150 | 11202 | Kit 3 Electrodes Blue Gel for Cefaly II | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Cefaly® | ||
| 7 | 05425018850143 | 11201 | Kit 3 electrodes for Cefaly II | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Cefaly® | ||
| 8 | 05425018850129 | 10205 | Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage bo Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage box- Power adapter + cable | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | Cefaly® | |
| 9 | 05425018850105 | 11106 | Kit 3 electrodes Blue Gel for Cefaly I | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Cefaly® | ||
| 10 | 05425018850044 | 11101 | Kit 3 electrodes for Cefaly I | PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Cefaly® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08800051500021 | ALLIVE01 | ALLIVE | NU EYNE CO., LTD. | ||
| 2 | 07290018393147 | RLV-PMI-102 | An application software program intended to extract, process, and store non-clin 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 | Relivion MG App | NEUROLIEF LTD | |
| 3 | 07290018393130 | RLV-PMI-101 | A cloud-based Patient Management Interface (PMI Physician Interface and cloud platform) | Relivion MG PMI Physician Interface | NEUROLIEF LTD | |
| 4 | 07290018393017 | PAD0001A | Electrode Pad Set | Relivion | NEUROLIEF LTD | |
| 5 | 07290018393000 | RLV3 | Relivion is a non-invasive medical device. It transfers mild electrical pulses t 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. | Relivion | NEUROLIEF LTD | |
| 6 | 06971760285003 | YF-HT-W1 | TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impul TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS deviceHeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses. | HeadaTerm | WAT MEDICAL TECHNOLOGY INC. | |
| 7 | 06971760280022 | YF-HT-W1 | TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impul TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS deviceHeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses. | HeadaTerm | WAT MEDICAL TECHNOLOGY INC. | |
| 8 | 05425018850310 | 11302 | Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes) | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 9 | 05425018850303 | 11301 | CEFALY Enhanced Electrode Kit .3 electrodes | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 10 | 05425018850273 | CEFALY DUAL Enhanced | 10601 | Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use:CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use.CEFALY DUAL Enhanced is indicated to be used for:The acute treatment of migraine with or without aura in patients 18 years of age or older.The preventative treatment of episodic migraine in patients 18 years of age or older. | Cefaly® | CEFALY TECHNOLOGY SPRL |
| 11 | 05425018850266 | Prevent | 10230 | The Cefaly® Prevent device is indicated for the prophylactic treatment of episod The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults. | Cefaly® | CEFALY TECHNOLOGY SPRL |
| 12 | 05425018850259 | Dual | 10505 | The Cefaly® Dual device is indicated for:- The acute treatment of migraine with 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. | Cefaly® | CEFALY TECHNOLOGY SPRL |
| 13 | 05425018850242 | Acute | 10405 | The Cefaly® Acute device is indicated for the acute treatment of migraine with o The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. | Cefaly® | CEFALY TECHNOLOGY SPRL |
| 14 | 05425018850150 | 11202 | Kit 3 Electrodes Blue Gel for Cefaly II | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 15 | 05425018850143 | 11201 | Kit 3 electrodes for Cefaly II | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 16 | 05425018850129 | 10205 | Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage bo Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage box- Power adapter + cable | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 17 | 05425018850105 | 11106 | Kit 3 electrodes Blue Gel for Cefaly I | Cefaly® | CEFALY TECHNOLOGY SPRL | |
| 18 | 05425018850044 | 11101 | Kit 3 electrodes for Cefaly I | Cefaly® | CEFALY TECHNOLOGY SPRL |