Device Classification Name |
stimulator, nerve, for restless legs syndrome
|
De Novo Number |
DEN220059 |
Device Name |
NTX100 Tonic Motor Activation (NTX100 ToMAc) System |
Requester |
Noctrix Health, Inc. |
6700 koll center pkwy, ste 310 |
pleasanton,
CA
94566
|
|
Contact |
shriram raghunathan |
|
Regulation Number | 882.5887
|
Classification Product Code |
|
Date Received | 09/21/2022 |
Decision Date | 04/17/2023 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|