Duns Number:643212926
Device Description: The device is intended for magnetic stimulation of peripheral nerves. The obtained respons 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.
Catalog Number
-
Brand Name
MEGA-TMS
Version/Model Number
MEGA-TMS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192823
Product Code
GWF
Product Code Name
Stimulator, Electrical, Evoked Response
Public Device Record Key
597e27b1-473a-460c-87b7-310d19b6cbdc
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
August 22, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |