Data / Medical devices / Italy / Spes Medica S.P.A

Spes Medica S.P.A: FDA-registered device maker in BATTIPAGLIA Salerno, Italy, 5 510(k) clearances

Name: Spes Medica S.P.A FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spes Medica S.P.A is registered with the FDA (registration 3005581220) in BATTIPAGLIA Salerno, Italy. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 22, 2019. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005581220
Address: Via Europa-Zona Industriale, BATTIPAGLIA Salerno, Italy, 84091
Owner or operator: Spes Medica S.p.A. (9082762)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: February 6, 2006
Registered through: 2026
Brand names listed: Disposable Adhesive Surface Electrodes, DryTouch Suction Stimulator, Spes Media Subdermal Needle Electrodes

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Needle, Diagnostic Electromyograph	IKT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Contract manufacturer, 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
November 22, 2019	K192603	Spes Medica Subdermal Needle Electrodes	GXZ	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
November 21, 2014	K133348	STIM PROBE	ETN	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
June 11, 2012	K120494	DISPOSABLE ADHESIVE SURFACE ELECTRODE	GXY	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
August 11, 2009	K091410	DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,	IKT	Substantially Equivalent	Spes Medica Srl	accessdata.fda.gov
May 10, 2006	K061148	RHYTHMLINK DISC ELECTRODES	GXY	Substantially Equivalent	Rhythmlink International, LLC	accessdata.fda.gov

Compare with other makers

Updated November 22, 2019. 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.