{ "code": "NUH", "deviceName": "Stimulator, Nerve, Transcutaneous, Over-The-Counter", "deviceClass": "II", "regulationNumber": "882.5890", "panel": "Neurology", "definition": "TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 229, "last12Months": 11 }, "adverseEvents": { "total": 19, "last12Months": 5 }, "reviewDays": { "median": 148, "sampleSize": 229 }, "recalls": { "total": 0, "recent": [] }, "recentClearances": [ { "kNumber": "K260412", "deviceName": "TENS 7000 Rechargeable 4 Channel (TENS 7000H)", "applicant": "Shenzhen Dongdixin Technology Co., Ltd.", "company": "Shenzhen Dongdixin Technology Co., Ltd.", "decisionDate": "2026-06-26", "dateReceived": "2026-02-09" }, { "kNumber": "K260425", "deviceName": "TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)", "applicant": "Hivox Biotek, Inc.", "company": "Hivox Biotek, Inc.", "decisionDate": "2026-06-16", "dateReceived": "2026-02-10" }, { "kNumber": "K253896", "deviceName": "TENS/EMS device (GUSE01)", "applicant": "Globalcare Medical Technology Co., Ltd.", "company": "Globalcare Medical Technology Co., Ltd.", "decisionDate": "2026-03-04", "dateReceived": "2025-12-05" }, { "kNumber": "K253305", "deviceName": "TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)", "applicant": "Shenzhen Jiantuo Electronics Co., Ltd.", "company": "Shenzhen Jiantuo Electronics Co., Ltd.", "decisionDate": "2025-12-31", "dateReceived": "2025-09-29" }, { "kNumber": "K253740", "deviceName": "TENS&EMS (HZ9151B, HZ9151C, HZ9151D)", "applicant": "Hong Qiangxing (Shenzhen) Electronics Limited", "company": "Hong Qiangxing (Shenzhen) Electronics Limited", "decisionDate": "2025-12-23", "dateReceived": "2025-11-24" }, { "kNumber": "K251958", "deviceName": "VEINOPLUS Back", "applicant": "Dynapulse Medical", "company": "DYNAPULSE MEDICAL LLC", "decisionDate": "2025-12-23", "dateReceived": "2025-06-25" }, { "kNumber": "K252688", "deviceName": "Transcutaneous Electrical Nerve Stimulator (RJTENS-2)", "applicant": "Bozhou Rongjian Medical Appliance Co., Ltd.", "company": "Bozhou Rongjian Medical Appliance Co., Ltd.", "decisionDate": "2025-11-24", "dateReceived": "2025-08-26" }, { "kNumber": "K251856", "deviceName": "Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4", "applicant": "Everyway Medical Instruments Co.,Ltd", "company": "EVERYWAY MEDICAL INSTRUMENTS CO., LTD.", "decisionDate": "2025-11-21", "dateReceived": "2025-06-17" }, { "kNumber": "K243131", "deviceName": "Triathlon Pro", "applicant": "Sigma Biomedical", "company": "Sigma Biomedical", "decisionDate": "2025-11-07", "dateReceived": "2024-09-30" }, { "kNumber": "K251429", "deviceName": "OTC 4-Channel Rechargeable TENS Unit", "applicant": "Changsha Anxiang Medical Technology Co., Ltd.", "company": "Changsha Anxiang Medical Technology Co., Ltd.", "decisionDate": "2025-08-28", "dateReceived": "2025-05-08" } ], "topApplicants": [ { "name": "Everyway Medical Instruments Co.,Ltd", "count": 14 }, { "name": "Hivox Biotek, Inc.", "count": 11 }, { "name": "Well-Life Healthcare Limited", "count": 11 }, { "name": "Shenzhen Kentro Medical Electronics Co., Ltd.", "count": 9 }, { "name": "Omron Healthcare, Inc.", "count": 7 } ], "topCompanies": [ { "name": "EVERYWAY MEDICAL INSTRUMENTS CO., LTD.", "count": 14, "spellings": 1 }, { "name": "Hivox Biotek, Inc.", "count": 11, "spellings": 1 }, { "name": "Well-Life Healthcare Limited", "count": 11, "spellings": 1 }, { "name": "Shenzhen Osto Technology Company Limited", "count": 10, "spellings": 2 }, { "name": "Shenzhen Kentro Medical Electronics Co., Ltd.", "count": 9, "spellings": 1 } ], "newEntrants": [ { "name": "Globalcare Medical Technology Co., Ltd.", "since": "2026-03-04", "kNumber": "K253896" }, { "name": "DYNAPULSE MEDICAL LLC", "since": "2025-12-23", "kNumber": "K251958" }, { "name": "Bozhou Rongjian Medical Appliance Co., Ltd.", "since": "2025-11-24", "kNumber": "K252688" }, { "name": "Sigma Biomedical", "since": "2025-11-07", "kNumber": "K243131" } ], "baseline": { "months": [ { "month": "2023-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter) has two findings, most consequential first. 4 first-time filers in the last 12 months, including Globalcare Medical Technology Co., Ltd. and DYNAPULSE MEDICAL LLC (K253896, K251958, K252688, K243131). The code is crowded, scoring 88 of 100 — 117 companies hold a clearance here and 11 arrived in the last 12 months (NUH:crowding).", "severity": 44, "factors": [ { "kind": "new_entrant", "detail": "4 first-time filers in the last 12 months, including Globalcare Medical Technology Co., Ltd. and DYNAPULSE MEDICAL LLC", "recordIds": [ "K253896", "K251958", "K252688", "K243131" ], "severity": 44 }, { "kind": "crowding", "detail": "the code is crowded, scoring 88 of 100 — 117 companies hold a clearance here and 11 arrived in the last 12 months", "recordIds": [ "NUH: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%3ANUH" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANUH" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANUH" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ANUH" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ANUH" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ANUH" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ANUH" } ], "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": "2026-08-11T13:51:45.749Z" }