{ "format": "devicerts.device.v1", "cite_as": "TENS One, TensCare Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/tens-one-k-tensone (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/tens-one-k-tensone", "json_url": "https://devicerts.com/devices/tens-one-k-tensone.json", "markdown_url": "https://devicerts.com/devices/tens-one-k-tensone.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" } ], "registry_records_last_synced": "2026-10-22", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/tens-one-k-tensone", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "TENS One", "registry_name": "TENS One", "url": "https://devicerts.com/devices/tens-one-k-tensone", "manufacturer": { "name": "TensCare Ltd", "url": "https://devicerts.com/manufacturers/tenscare-ltd", "country": "United Kingdom", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union" }, "classification": [ { "class": "Class IIa", "system": "EU MDR" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "K-TENSONE", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "05033435136339", "registries": [ "EUDAMED" ] }, { "value": "05033435134045", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "5033435K00075DSY", "registries": [ "EUDAMED" ] }, { "value": "5033435E00075XF", "registries": [ "EUDAMED" ] } ] } ], "product_codes": [ "NUH" ], "emdn": [ { "code": "Z120622", "term": "MUSCLE STIMULATORS" } ], "gmdn": [ { "code": "35372", "term": "Analgesic transcutaneous electrical nerve stimulation system" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDR", "number": "5033435K00075DSY", "number_label": "Basic UDI-DI", "device_udi_di": null, "date": "2024-08-22", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "05033435136339", "number_label": "UDI-DI", "device_udi_di": null, "date": "2019-08-05", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "TENS One", "registries": [ "EUDAMED" ] }, { "value": "Tenscare", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Analgesic transcutaneous electrical nerve stimulation system", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "K-TENSONE", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "TENS One", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "05033435136339", "registries": [ "EUDAMED" ] }, { "value": "05033435134045", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "5033435K00075DSY", "registries": [ "EUDAMED" ] }, { "value": "5033435E00075XF", "registries": [ "EUDAMED" ] } ] }, { "label": "FDA product code", "values": [ { "value": "NUH", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z120622", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Analgesic transcutaneous electrical nerve stimulation system", "code": "35372", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIa", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "882.5890", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "System or procedure pack", "values": [ { "value": "Procedure pack", "registries": [ "EUDAMED" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Standard device", "registries": [ "EUDAMED" ] }, { "value": "System or procedure pack", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Denmark", "registries": [ "EUDAMED" ] } ] }, { "label": "Medical purpose", "values": [ { "value": "TENS One is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.\nThe device is suitable for use by all who can control the device and understand the instructions.", "registries": [ "EUDAMED" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Over-the-counter", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": 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(AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }