Data / Medical devices / Sweden / Jolife AB

Jolife AB: FDA-registered device maker in LUND Skane, Sweden, 3 510(k) clearances

Name: Jolife AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jolife AB is registered with the FDA (registration 3005445717) in LUND Skane, Sweden. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 8, 2018. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005445717
Address: Ideon Science Park Scheelevagen 17, LUND Skane, Sweden, 22370
Owner or operator: STRYKER CORP. (1811755)
Roles: Specification developer
First device listed: December 13, 2017
Registered through: 2026
Brand names listed: LUCAS 2, LUCAS 2 Battery, LUCAS 3, LUCAS ANTI SLIP, SLIM BACK PLATE, LUCAS BATTERY, DARK GRAY, LUCAS Back Plate Grip Tape, LUCAS Battery Charger with Cord, LUCAS Car Cable 12V and more

Devices it lists

Device	Product code	Class	Role	Source
Compressor, Cardiac, External	DRM	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 8, 2018	K173553	LUCAS 3 Chest Compression System	DRM	Substantially Equivalent	Jolife AB	accessdata.fda.gov
November 9, 2016	K161768	LUCAS 3 Chest Compression System	DRM	Substantially Equivalent	Jolife AB	accessdata.fda.gov
June 17, 2009	K090422	LUCAS 2	DRM	Substantially Equivalent	Jolife AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 13, 2026	98417	Class II	Ongoing	LUCAS 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 Ca	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).	accessdata.fda.gov
May 21, 2025	96729	Class II	Ongoing	LUCAS 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	Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.	accessdata.fda.gov
February 8, 2011	57967	Not yet classified	Terminated	LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System*jolifewww.lucas-cpr.coma product by JOLIFE*MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevag	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.	accessdata.fda.gov

Compare with other makers

All makers of Compressor, Cardiac, External

Updated May 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.