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: Flow Am coil adapter kit, ø29-2pcs. Approved with Flow Arm (9016B0801). FDA UDI
Model / Reference: Flow Am coil adapter kit, ø29-2pcs FDA UDI
Description: Flow Am coil adapter kit, ø29-2pcs. Approved with Flow Arm (9016B0801). FDA UDI

Identifiers

Catalog Number: 9016B0841 FDA UDI
Primary DI / UDI-DI: 05713484031303 FDA UDI
510(k) Number: K061645 FDA UDI
K193006 FDA UDI
FDA Product Code: QCI FDA UDI
GWF FDA UDI
GMDN Term: Magnetic neural stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5802 FDA UDI
882.1870 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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NeuroStar System Software — Neuronetics Inc. · Class II
Power Supply Module - 115V — Brainsway , Ltd. · Class II
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 2232347c-4244-46f5-b8f5-903b04cf56d3 36 fields · synced Jun 8, 2026