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Mega-Tms

FDA UDI

Class II (US FDA UDI)

by Neurosoft, Ooo

Identity

Trade Name
MEGA-TMS FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Device Name
The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation. FDA UDI
Model / Reference
MEGA-TMS FDA UDI
Description
The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation. FDA UDI

Identifiers

Primary DI / UDI-DI
04650075333174 FDA UDI
510(k) Number
K192823 FDA UDI
FDA Product Code
GWF FDA UDI
GMDN Term
Magnetic neural stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic neural stimulation system

Mega-Tms by Neurosoft, Ooo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic neural stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurosoft, Ooo

Sources (1)

  • FDA UDI 597e27b1-473a-460c-87b7-310d19b6cbdc 35 fields · synced Jun 6, 2026