510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Jolife AB

LUND Skane, SE

JOLIFE AB appears in FDA device records in LUND Skane, SE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Jolife AB between 2006 and 2018. The busiest year on record is 2006, with 2. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Jolife AB, by decision year
YearClearances
20062
20091
20161
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173553LUCAS 3 Chest Compression SystemDRMSubstantially Equivalent
K161768LUCAS 3 Chest Compression SystemDRMSubstantially Equivalent
K090422LUCAS 2DRMSubstantially Equivalent
K062401MODIFICATION TO LUCASDRMSubstantially Equivalent
K053403LUCASDRMSubstantially Equivalent

Registered establishments

FDA registered establishments for Jolife AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30054457173005445717JOLIFE ABIDEON SCIENCE PARK, LUND Skane 22370 SE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2161-2026LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).Class IIOpen, Classified
Z-1998-2025LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.Class IIOpen, Classified
Z-1664-2011LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". Designed to uninterrupted chest compressions at a consistent rate and depth.LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain