{
  "code": "IPF",
  "deviceName": "Stimulator, Muscle, Powered",
  "deviceClass": "II",
  "regulationNumber": "890.5850",
  "panel": "Physical Medicine",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 548,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 25,
    "last12Months": 9
  },
  "reviewDays": {
    "median": 108,
    "sampleSize": 548
  },
  "recalls": {
    "total": 7,
    "recent": [
      {
        "resNumber": "Z-0506-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Liberty Medical Solutions, LLC",
        "firmAsPublished": "Liberty Medical Solutions, LLC",
        "reason": "The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.",
        "initiated": "2023-11-03"
      },
      {
        "resNumber": "Z-1137-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Ion Genius, Inc.",
        "firmAsPublished": "Ion Genius, Inc.",
        "reason": "Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA",
        "initiated": "2012-01-06"
      },
      {
        "resNumber": "Z-1138-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Ion Genius, Inc.",
        "firmAsPublished": "Ion Genius, Inc.",
        "reason": "Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA",
        "initiated": "2012-01-06"
      },
      {
        "resNumber": "Z-1141-2012",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Ion Genius, Inc.",
        "firmAsPublished": "Ion Genius, Inc.",
        "reason": "Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA",
        "initiated": "2012-01-06"
      },
      {
        "resNumber": "Z-2880-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "eSwallow USA LLC",
        "firmAsPublished": "eSwallow USA LLC",
        "reason": "It was discovered that the firm was distributing medical devices without FDA approval.",
        "initiated": "2011-06-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253542",
      "deviceName": "Apollo Quattro (APQ-10M)",
      "applicant": "Weero Co., Ltd.",
      "company": "Weero Co., Ltd.",
      "decisionDate": "2026-06-08",
      "dateReceived": "2025-11-14"
    },
    {
      "kNumber": "K252816",
      "deviceName": "High Tone Power therapy (HiToP) (Model: HiToP PNP)",
      "applicant": "Mohammadali Nezakati",
      "company": "Mohammadali Nezakati",
      "decisionDate": "2026-06-02",
      "dateReceived": "2025-09-04"
    },
    {
      "kNumber": "K260142",
      "deviceName": "StimelMD (SSMD) system",
      "applicant": "Motion Informatics ltd.",
      "company": "Motion Informatics ltd.",
      "decisionDate": "2026-05-27",
      "dateReceived": "2026-01-20"
    },
    {
      "kNumber": "K251083",
      "deviceName": "Compact II",
      "applicant": "Enraf-Nonius, B.V.",
      "company": "Enraf-Nonius, B.V.",
      "decisionDate": "2025-09-12",
      "dateReceived": "2025-04-09"
    },
    {
      "kNumber": "K241433",
      "deviceName": "EVE Synergy (EVE-20M)",
      "applicant": "Weero Co., Ltd.",
      "company": "Weero Co., Ltd.",
      "decisionDate": "2025-06-04",
      "dateReceived": "2024-05-21"
    },
    {
      "kNumber": "K241488",
      "deviceName": "TrainFES Advance",
      "applicant": "Trainfes",
      "company": "Trainfes",
      "decisionDate": "2025-02-05",
      "dateReceived": "2024-05-24"
    },
    {
      "kNumber": "K240348",
      "deviceName": "Quantum Mitohormesis (QMT) (M2101)",
      "applicant": "Quantumtx Pte. , Ltd.",
      "company": "Quantumtx Pte. , Ltd.",
      "decisionDate": "2024-12-19",
      "dateReceived": "2024-02-05"
    },
    {
      "kNumber": "K240992",
      "deviceName": "eMVFit (MVF-10M)",
      "applicant": "Weero Co., Ltd.",
      "company": "Weero Co., Ltd.",
      "decisionDate": "2024-10-10",
      "dateReceived": "2024-04-11"
    },
    {
      "kNumber": "K240234",
      "deviceName": "BTL-899MS",
      "applicant": "BTL Industries, Inc.",
      "company": "BTL Industries, Inc.",
      "decisionDate": "2024-08-17",
      "dateReceived": "2024-01-29"
    },
    {
      "kNumber": "K233098",
      "deviceName": "MYOTouch Muscle Stimulator",
      "applicant": "Sunmed, LLC",
      "company": "Sunmed, Inc.",
      "decisionDate": "2024-08-02",
      "dateReceived": "2023-09-26"
    }
  ],
  "topApplicants": [
    {
      "name": "Rich-Mar Corp.",
      "count": 17
    },
    {
      "name": "Bloomex International, Inc.",
      "count": 14
    },
    {
      "name": "Chattanooga Group, Inc.",
      "count": 11
    },
    {
      "name": "Maximum Performance Technologies, Mpts, Inc.",
      "count": 11
    },
    {
      "name": "Mettler Electronics Corp.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Rich-Mar Corp.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Bloomex International, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Chattanooga Group, Inc.",
      "count": 14,
      "spellings": 2
    },
    {
      "name": "Mettler Electronics Corporation",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "Maximum Performance Technologies, Mpts, Inc.",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Mohammadali Nezakati",
      "since": "2026-06-02",
      "kNumber": "K252816"
    },
    {
      "name": "Motion Informatics ltd.",
      "since": "2026-05-27",
      "kNumber": "K260142"
    },
    {
      "name": "Enraf-Nonius, B.V.",
      "since": "2025-09-12",
      "kNumber": "K251083"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "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": "IPF (Stimulator, Muscle, Powered) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Mohammadali Nezakati and Motion Informatics ltd (K252816, K260142, K251083). The code is crowded, scoring 86 of 100 — 303 companies hold a clearance here and 4 arrived in the last 12 months (IPF:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Mohammadali Nezakati and Motion Informatics ltd.",
        "recordIds": [
          "K252816",
          "K260142",
          "K251083"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 86 of 100 — 303 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "IPF: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%3AIPF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIPF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AIPF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AIPF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AIPF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AIPF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AIPF"
    }
  ],
  "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": "2026-08-11T13:51:45.712Z"
}