NTX100 Tonic Motor Activation (NTX100 ToMAc) System
FDA 510(k) clearance DEN220059 · decided 2023-04-17
Clearance details
- K-number
- DEN220059
- Device name
- NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- Applicant
- Noctrix Health, Inc.
- Decision
- Unknown
- Date received
- 2022-09-21
- Decision date
- 2023-04-17
- Days to decision
- 208 days
- Clearance type
- Direct
- Product code
- QWD
- Device class
- 2
- Regulation number
- 882.5887
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.