MagPro Accessories Foot Rest Cover 9016B0451: CE/MDR Class I

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number5713484TreatmentChairHM Basic UDI-DI 05713484030306UDI-DI	Date4 Nov 2026Registered	StatusActive
United States	GUDID listing GUDID	Number05713484030306 UDI-DI	Date28 Nov 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK193006	Date9 Aug 2020Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK150641	Date31 Jul 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 5713484TreatmentChairHM — open Devices and search for it
AccessGUDID record UDI-DI 05713484030306
FDA 510(k) database 510(k) number K193006
FDA 510(k) database 510(k) number K150641

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 5713484TreatmentChairHM registered 4 Nov 2026 Active
FDA 510(k) K193006 decided 9 Aug 2020 Active· +1 more in the status table
FDA GUDID UDI-DI 05713484030306 listed 28 Nov 2022 Listed

Timeline

4 dated events

31 Jul 2015 Cleared FDA 510(k) K150641
9 Aug 2020 Cleared FDA 510(k) K193006
28 Nov 2022 Listed FDA GUDID 05713484030306
4 Nov 2026 Registered EUDAMED 5713484TreatmentChairHM

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Foot rest cover for Treatment Chair EUDAMED
MagPro Accessories GUDID
Generic name: Magnetic neural stimulation system
Device name: Treatment Chair with neckrest
Model / Ref / Catalog: 9016B0451, Foot Rest Cover
Description: Approved with Treatment Chair (9016B0081). Plastic cover for the foot rest of the treatment chair.

Primary DI / UDI-DI: 05713484030306
Basic UDI-DI: 5713484TreatmentChairHM
510(k) Number: K150641
K193006
FDA product code: OBP, QCI
EMDN code: Z12101180 Peripheral or central neuro stimulation and assessment instruments - hardware accessories
GMDN term: Magnetic neural stimulation system

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 882.5805, 882.5802
EU registration type: Standard device
EU market of registration: Denmark
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED 9016B0451	GUDID Foot Rest Cover
Device class	EUDAMED Class I	GUDID Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.