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Termosalud S.L.: FDA-registered device maker in Gijon Asturias(Autonomous Community), Spain, 7 510(k) clearances

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

Termosalud S.L. is registered with the FDA (registration 3026400760) in Gijon Asturias(Autonomous Community), Spain. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3026400760
Address: Ataulfo Friera Tarfe 8, Gijon Asturias(Autonomous Community), Spain, 33211
Owner or operator: Termosalud S.L. (10087295)
Roles: Manufacturer
First device listed: February 9, 2023
Registered through: 2027
Brand names listed: DEEP2, ENEKA PRO, ENEKA SELECTIF, MASSAGE & O2XY, SYMMED ELITE AESTHETIC, VMAT PRO, Z-CAP ZIONIC PRO MAX HP, Z-EMS and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	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
March 12, 2026	K253636	Zionic Pro Max (EMS)	NGX	Substantially Equivalent	Termosalud S.L.	accessdata.fda.gov
May 28, 2025	K243716	Zionic Pro Max (Radiofrequency)	PBX	Substantially Equivalent	Termosalud S.L.	accessdata.fda.gov
February 6, 2025	K243488	VMAT PRO	ISA	Substantially Equivalent	Termosalud	accessdata.fda.gov
August 12, 2024	K241656	Eneka Selectif	GEX	Substantially Equivalent	Termosalud	accessdata.fda.gov
June 8, 2023	K230659	Zionic Aesthetic	PBX	Substantially Equivalent	Termosalud	accessdata.fda.gov
April 13, 2023	K230412	Symmed Elite Aesthetic	PBX	Substantially Equivalent	Termosalud	accessdata.fda.gov
February 10, 2023	K223680	Eneka Pro	GEX	Substantially Equivalent	Termosalud	accessdata.fda.gov

Compare with other makers

Updated March 12, 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.