{ "format": "devicerts.device.v1", "cite_as": "Permobil M1, Permobil, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/permobil-m1 (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/permobil-m1", "json_url": "https://devicerts.com/devices/permobil-m1.json", "markdown_url": "https://devicerts.com/devices/permobil-m1.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "registry_records_last_synced": "2026-10-23", "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/permobil-m1", "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": "Permobil M1", "registry_name": "Permobil M1", "url": "https://devicerts.com/devices/permobil-m1", "manufacturer": { "name": "Permobil, Inc.", "url": "https://devicerts.com/manufacturers/fda-fei-3004908349", "country": "Sweden", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "17330818252316", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K123290", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "ITI" ], "emdn": [], "gmdn": [ { "code": "41875", "term": "Electric-motor-driven wheelchair, occupant-controlled" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "17330818252316", "number_label": "UDI-DI", "device_udi_di": null, "date": "2017-08-09", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K123290", "number_label": null, "device_udi_di": null, "date": "2013-04-17", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-2805-2026", "classification": "Class II", "status": "ongoing", "initiated": "2025-06-19", "reason": "This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances.", "applies": "this device", "via": "K123290" }, { "number": "Z-2795-2026", "classification": "Class II", "status": "ongoing", "initiated": "2024-02-29", "reason": "This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,", "applies": "this device", "via": "K123290" }, { "number": "Z-3178-2018", "classification": "Class II", "status": "terminated", "initiated": "2018-08-15", "reason": "This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.", "applies": "this device", "via": "K123290" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "Permobil", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Electric-motor-driven wheelchair, occupant-controlled", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / reference", "values": [ { "value": "M1", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "17330818252316", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K123290", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "ITI", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Electric-motor-driven wheelchair, occupant-controlled", "code": "41875", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class II", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation number", "values": [ { "value": "890.3860", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "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": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Prescription use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }