{
  "schemaVersion": "2.0.0",
  "identity": {
    "slug": "electrocore-gammacore-sapphire",
    "manufacturerSlug": "electrocore",
    "name": {
      "value": "gammaCore Sapphire",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modelNumber": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "codename": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "aliases": {
      "value": [
        "electroCore gammaCore",
        "gammaCore"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "generation": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "predecessorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "successorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "tagline": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial copy — not a sourced fact"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "shortDescription": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial prose — not a sourced fact"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "longDescription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "countryOfOrigin": {
      "value": "US",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "releaseDate": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 said 2017; not pinned in primary electroCore sources"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "announcedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "discontinuedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "status": {
      "value": "shipping",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "classification": {
    "invasiveness": {
      "value": "non-invasive",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modalities": {
      "value": [
        "tVNS"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "primaryModality": {
      "value": "tVNS",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "direction": {
      "value": "write",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "category": {
      "value": [
        "therapeutic",
        "stimulation",
        "clinical-grade"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "formFactor": {
      "value": [
        "handheld"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "intendedUseCases": {
      "value": [
        "acute treatment of migraine pain in adults",
        "preventive treatment of migraine in adolescents (12+) and adults",
        "acute treatment of episodic cluster headache",
        "paroxysmal hemicrania and hemicrania continua"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "targetUsers": {
      "value": [
        "general-consumer",
        "clinician"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "stimulation": {
    "capable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "connectivity": {
    "protocols": {
      "value": [
        "bluetooth-le"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bluetoothVersion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bluetoothProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "concurrentMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "encryptionInTransit": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "pairingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudSync": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineRecording": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "power": {
    "sources": {
      "value": [
        "rechargeable-li-po"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "batteryLifeActiveHours": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingPort": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "batteryReplaceable": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "physical": {
    "weightGrams": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dimensions": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "materials": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sizes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "headCircumferenceCm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "operatingTempC": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "software": {
    "apps": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "mobileApp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudPlatform": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscriptionRequired": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawDataAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "exportFormats": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "lslSupport": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dataOwnership": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "privacyPolicyUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "sdk": {
    "hasSdk": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "docsUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "openSource": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "languages": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "webBluetooth": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rawSampleAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bciParadigms": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "thirdPartyIntegrations": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "capabilities": {
    "attentionFocus": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCalm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "neurofeedback": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCoaching": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sleepTracking": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "customCapabilities": {
      "value": [
        {
          "name": "Two-minute non-invasive cervical VNS",
          "description": "Held against the side of the neck for 2-min stimulation cycles; FDA De Novo (DEN150048) + 510(k) K182369 indications cover migraine, cluster headache, hemicrania.",
          "evidenceLevel": "fda-cleared"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150048.pdf",
          "label": "FDA De Novo DEN150048 — gammaCore"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182369.pdf",
          "label": "FDA 510(k) K182369 — gammaCore migraine indication"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "regulatory": {
    "fdaStatus": {
      "value": "de-novo",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150048.pdf",
          "label": "FDA De Novo DEN150048 — gammaCore"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "ceMark": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "certifications": {
      "value": [
        "FDA De Novo DEN150048",
        "FDA 510(k) K182369 (migraine indication)"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150048.pdf",
          "label": "FDA De Novo DEN150048 — gammaCore"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182369.pdf",
          "label": "FDA 510(k) K182369 — gammaCore migraine indication"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "prescriptionRequired": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "pediatricApproved": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "pricing": {
    "msrp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "currentPrice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "buyUrls": {
      "value": [
        {
          "region": "us",
          "vendor": "gammaCore",
          "url": "https://www.gammacore.com"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.gammacore.com",
          "label": "gammaCore — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "warranty": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "returnPolicyDays": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "editorial": {
    "pros": [
      "Non-invasive cervical VNS — no implant required",
      "Multiple FDA-cleared headache indications",
      "Pediatric (12+) preventive use approved"
    ],
    "cons": [
      "Prescription-required",
      "On-demand 2-min cycles can be inconvenient during prodrome"
    ],
    "bestFor": [],
    "notFor": [],
    "comparableDevices": [
      "cefaly-dual",
      "neurosigma-monarch-etns",
      "livanova-sentiva"
    ]
  },
  "provenance": {
    "sources": [
      {
        "label": "gammaCore — official site",
        "url": "https://www.gammacore.com"
      },
      {
        "label": "FDA De Novo DEN150048 — gammaCore",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150048.pdf"
      },
      {
        "label": "FDA 510(k) K182369 — gammaCore migraine",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182369.pdf"
      }
    ],
    "lastReviewedAt": "2026-05-07"
  }
}