MagPro Accessories

FDA UDI

Class II (US FDA UDI)

by Tonica Elektronik A/S

Identity

Trade Name: MagPro Accessories FDA UDI
Generic Name: Magnetic neural stimulation system FDA UDI
Device Name: Approved with Treatment Chair (9016B0081). Cloth cover for treatment chair. FDA UDI
Model / Reference: Terry Cover FDA UDI
Description: Approved with Treatment Chair (9016B0081). Cloth cover for treatment chair. FDA UDI

Identifiers

Catalog Number: 9016B0461 FDA UDI
Primary DI / UDI-DI: 05713484030313 FDA UDI
510(k) Number: K150641 FDA UDI
K193006 FDA UDI
FDA Product Code: OBP FDA UDI
QCI FDA UDI
GMDN Term: Magnetic neural stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5805 FDA UDI
882.5802 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Magnetic neural stimulation system

MagPro Accessories by Tonica Elektronik A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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NQ TMS — Neuroqore, Inc. · Class II

Cleared under the same submission

K193006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tonica Elektronik A/S

Sources (1)

FDA UDI b85ab95e-f9c0-460a-9d7f-d8afc68c1ae0 35 fields · synced May 30, 2026