Data / Medical devices / Liechtenstein / BEMER Int. AG

BEMER Int. AG: FDA-registered device maker in Triesen, Liechtenstein, 4 510(k) clearances

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

BEMER Int. AG is registered with the FDA (registration 3009102830) in Triesen, Liechtenstein. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 23, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009102830
Address: Austrasse 15, Triesen, Liechtenstein, 9495
Owner or operator: BEMER Int. AG (10035841)
Roles: Exporter to the US, Manufacturer
First device listed: February 28, 2017
Registered through: 2027
Brand names listed: BEMER Pro-Set, BEMER Pro-Set, B.BODY, B.SIT, Home-Pack, Go-Pack, Basic-Pack, Office-Pack, BEMER Therapy System Evo, B.Box Evo, B.Body Evo, B.Bed Evo, B.Sit Evo, B.Pad Evo, B.Spot Evo, Light Pack Evo - B.Light Clear Evo and B.Light Restore Evo

Devices it lists

Device	Product code	Class	Role	Source
Light Based Over The Counter Wrinkle Reduction	OHS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US, Manufacturer	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
September 23, 2023	K223919	B.Light Clear Evo and B.Light Restore Evo	OHS	Substantially Equivalent	Bemer Int AG	accessdata.fda.gov
June 9, 2023	K231368	Bemer Therapy System Evo	NGX	Substantially Equivalent	Bemer Int AG	accessdata.fda.gov
February 4, 2021	K210174	BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set	NGX	Substantially Equivalent	Bemer Int AG	accessdata.fda.gov
February 22, 2017	K151834	BEMER Classic Set, BEMER Pro-Set	NGX	Substantially Equivalent	Bemer Int AG	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
January 13, 2021	87094	Class II	Terminated	Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.	accessdata.fda.gov

Compare with other makers

Updated September 23, 2023. 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.