Duns Number:495566056
Device Description: The DuoMAG NL is intended to stimulate peripheral nerves for relief of chronic intractable The DuoMAG NL is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain.DuoMAG NL consists of a Magnetic stimulator DuoMAG XT-NL, stimulation coil, trolley MagCart, and LiquidCool System unit.
Catalog Number
DM-NL
Brand Name
DuoMAG NL
Version/Model Number
DM-NL
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210021
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
4b0bc2ab-fdbd-4898-864d-9d339342e05d
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
June 29, 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. | 3 |