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Hasomed GMBH: FDA-registered device maker in Magdeburg Saxony-Anhalt, Germany, 2 510(k) clearances

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

Hasomed GMBH is registered with the FDA (registration 3006141275) in Magdeburg Saxony-Anhalt, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 3, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006141275
Address: Paul-Ecke-Strasse 1, Magdeburg Saxony-Anhalt, Germany, 39114
Owner or operator: HASOMED GmbH (10024229)
Roles: Manufacturer
First device listed: November 9, 2011
Registered through: 2026
Brand names listed: RehaCom, RehaCom Keyboard, RehaStim 2 & RehaMove 2

Devices it lists

Device	Product code	Class	Role	Source
Computerized Cognitive Assessment Aid, Exempt	PTY	2	Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Manufacturer	accessdata.fda.gov
System, Communication, Powered	ILQ	2	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
February 3, 2017	K162683	RehaStim 2	GZI	Substantially Equivalent	Hasomed GmbH	accessdata.fda.gov
October 27, 2011	K112844	REHASTIM 2, REHAMOVE 2	GZI	Substantially Equivalent	Hasomed GmbH	accessdata.fda.gov

Compare with other makers

Updated February 3, 2017. 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.