{ "format": "devicerts.device.v1", "cite_as": "Perfect EMS, TensCare Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/perfect-ems-k-pems (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/perfect-ems-k-pems", "json_url": "https://devicerts.com/devices/perfect-ems-k-pems.json", "markdown_url": "https://devicerts.com/devices/perfect-ems-k-pems.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": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" } ], "registry_records_last_synced": "2026-10-24", "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/perfect-ems-k-pems", "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": "Perfect EMS", "registry_name": "Perfect EMS", "url": "https://devicerts.com/devices/perfect-ems-k-pems", "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 and United States" }, "classification": [ { "class": "Class IIa", "system": "EU MDR" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "K-PEMS", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "05033435131419", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "5033435K00045ZL", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K200694", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "NGX", "NUH" ], "emdn": [ { "code": "Z12062801", "term": "MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES" } ], "gmdn": [ { "code": "46573", "term": "Physical therapy transcutaneous neuromuscular electrical stimulation system" } ], "description": null, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDR", "number": "5033435K00045ZL", "number_label": "Basic UDI-DI", "device_udi_di": "05033435131419", "date": "2024-06-04", "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": "05033435131419", "number_label": "UDI-DI", "device_udi_di": null, "date": "2023-08-31", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K200694", "number_label": null, "device_udi_di": null, "date": "2021-06-04", "date_kind": "issued", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Perfect EMS", "registries": [ "EUDAMED" ] }, { "value": "TensCare", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Physical therapy transcutaneous neuromuscular electrical stimulation system", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "K-PEMS", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "Perfect EMS", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "05033435131419", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "5033435K00045ZL", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K200694", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "NGX", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "NUH", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12062801", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Physical therapy transcutaneous neuromuscular electrical stimulation system", "code": "46573", "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": "890.5850", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "882.5890", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "System or procedure pack", "values": [ { "value": "Procedure pack", "registries": [ 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