510(k) DEN220059
- Device
- NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- Applicant
- Noctrix Health, Inc.
- 510(k) number
- DEN220059
- Product code
- QWD
- Decision
- Unknown (DENG)
- Decision date
- 2023-04-17
- Date received
- 2022-09-21
- Regulation
- 882.5887
- Classification name
- Stimulator, Nerve, For Restless Legs Syndrome
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shriram Raghunathan
- Address
- 6700 Koll Center Pkwy., Suite 310 Pleasanton CA US 94566 94566
FDA Registration Numbers#
- 3025729280
- 3032776111
- 9710609
Source Documents#
510(k) summary PDF not indicated by FDA