{
  "code": "GZJ",
  "deviceName": "Stimulator, Nerve, Transcutaneous, For Pain Relief",
  "deviceClass": "II",
  "regulationNumber": "882.5890",
  "panel": "Neurology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 606,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 60,
    "last12Months": 7
  },
  "reviewDays": {
    "median": 112,
    "sampleSize": 606
  },
  "recalls": {
    "total": 7,
    "recent": [
      {
        "resNumber": "Z-2105-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Neuro Resource Group, Inc.",
        "firmAsPublished": "Neuro Resource Group Inc",
        "reason": "Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.",
        "initiated": "2011-02-07"
      },
      {
        "resNumber": "Z-1440-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Synaptic Corp",
        "firmAsPublished": "Synaptic Corp",
        "reason": "Device was distributed without marketing approval.",
        "initiated": "2008-07-18"
      },
      {
        "resNumber": "Z-1207-2007",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Avazzia, Inc.",
        "firmAsPublished": "Avazzia, Inc",
        "reason": "Plastic Cases may crack due to manufacturing by the supplier not meeting specifications",
        "initiated": "2007-06-29"
      },
      {
        "resNumber": "Z-1208-2007",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Avazzia, Inc.",
        "firmAsPublished": "Avazzia, Inc",
        "reason": "Plastic Cases may crack due to manufacturing by the supplier not meeting specifications",
        "initiated": "2007-06-29"
      },
      {
        "resNumber": "Z-1209-2007",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Avazzia, Inc.",
        "firmAsPublished": "Avazzia, Inc",
        "reason": "Plastic Cases may crack due to manufacturing by the supplier not meeting specifications",
        "initiated": "2007-06-29"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252712",
      "deviceName": "STIMPOD NMS460 Nerve Stimulator",
      "applicant": "Algiamed Technologies USA, Inc.",
      "company": "Algiamed Technologies USA, Inc.",
      "decisionDate": "2026-05-28",
      "dateReceived": "2025-08-27"
    },
    {
      "kNumber": "K252767",
      "deviceName": "actiTENS mini",
      "applicant": "Sublimed",
      "company": "Sublimed",
      "decisionDate": "2026-01-16",
      "dateReceived": "2025-08-29"
    },
    {
      "kNumber": "K252236",
      "deviceName": "CP Relief Wand Rx - TENS/NMES",
      "applicant": "N & C Holdings, LLC",
      "company": "N & C Holdings, LLC",
      "decisionDate": "2025-08-15",
      "dateReceived": "2025-07-17"
    },
    {
      "kNumber": "K232441",
      "deviceName": "Unipro (K-UNIPRO-US)",
      "applicant": "Tenscare, Ltd.",
      "company": "Tenscare, Ltd.",
      "decisionDate": "2024-08-30",
      "dateReceived": "2023-08-14"
    },
    {
      "kNumber": "K241228",
      "deviceName": "TENSWave",
      "applicant": "Zynex Medical Officer",
      "company": "Zynex Medical Officer",
      "decisionDate": "2024-08-27",
      "dateReceived": "2024-05-02"
    },
    {
      "kNumber": "K233046",
      "deviceName": "Electrical Neuromuscular Stimulator, Cure Trio",
      "applicant": "Oriental Inspiration Limited",
      "company": "Oriental Inspiration Limited",
      "decisionDate": "2024-04-19",
      "dateReceived": "2023-09-25"
    },
    {
      "kNumber": "K222879",
      "deviceName": "Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)",
      "applicant": "Wuxi Jiajian Medical Instrument Co., Ltd.",
      "company": "Wuxi Jiajian Medical Instrument Co., Ltd.",
      "decisionDate": "2023-01-24",
      "dateReceived": "2022-09-22"
    },
    {
      "kNumber": "K212618",
      "deviceName": "iRelieve Microcurrent Pain Relief System",
      "applicant": "Fast Track Technologies, Inc.",
      "company": "Fast Track Technologies, Inc.",
      "decisionDate": "2022-09-14",
      "dateReceived": "2021-08-18"
    },
    {
      "kNumber": "K213802",
      "deviceName": "StimOnTM Pain Relief System (GM2439)",
      "applicant": "Gimer Medical Co., Ltd.",
      "company": "Gimer Medical Co., Ltd.",
      "decisionDate": "2022-08-26",
      "dateReceived": "2021-12-06"
    },
    {
      "kNumber": "K220578",
      "deviceName": "Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)",
      "applicant": "Bozhou Rongjian Medical Appliance Co., Ltd.",
      "company": "Bozhou Rongjian Medical Appliance Co., Ltd.",
      "decisionDate": "2022-05-25",
      "dateReceived": "2022-02-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Biomedical Life Systems, Inc.",
      "count": 20
    },
    {
      "name": "Empi",
      "count": 17
    },
    {
      "name": "Medical Devices, Inc.",
      "count": 16
    },
    {
      "name": "American Imex",
      "count": 11
    },
    {
      "name": "Bio-Medical Research, Ltd.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "Biomedical Life Systems, Inc.",
      "count": 22,
      "spellings": 2
    },
    {
      "name": "Empi",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Medical Devices (Pvt) , Ltd.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "American Imex",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Bio-Medical Research Corp.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Algiamed Technologies USA, Inc.",
      "since": "2026-05-28",
      "kNumber": "K252712"
    },
    {
      "name": "N & C Holdings, LLC",
      "since": "2025-08-15",
      "kNumber": "K252236"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief) has two findings, most consequential first. 2 first-time filers in the last 12 months, Algiamed Technologies USA, Inc. and N & C Holdings, LLC (K252712, K252236). The code is crowded, scoring 81 of 100 — 319 companies hold a clearance here and 3 arrived in the last 12 months (GZJ:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Algiamed Technologies USA, Inc. and N & C Holdings, LLC",
        "recordIds": [
          "K252712",
          "K252236"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 81 of 100 — 319 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "GZJ:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AGZJ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGZJ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGZJ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGZJ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGZJ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGZJ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGZJ"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.706Z"
}