| 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., suite 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
|
| Classification Order |
Classification Order
|
| FDA Review |
Decision Summary
|
| Type |
Direct
|
Predetermined Change Control Plan Authorized |
No
|
|
|