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510(k) Data Aggregation
K Number
DEN220059Device Name
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
Manufacturer
Date Cleared
2023-04-17
(208 days)
Regulation Number
882.5887Why did this record match?
Applicant Name (Manufacturer) :
Noctrix Health, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NTX100 Tonic Motor Activation (ToMAc) System® is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to improve sleep quality in adults refractory to medications.
Device Description
The NTX100 Tonic Motor Activation (ToMAc) System® is a non-surgical, non-implantable prescription device intended for the application of low-amplitude electrical stimulation to the common peroneal nerve at lateral side of the knees to reduce symptoms of moderate-severe Restless Legs Syndrome (RLS). Patients will be instructed to use the NTX100 ToMAc System® as needed for symptom relief for up to 120 minutes per 24-hour period.
The primary components of the NTX100 ToMAc System® include:
- . Therapy Unit
- Charge Dispersing Interface (CDI) .
- . Charging accessories
- Clinician App (for clinician use only) .
- . Clinician Computer (for clinician use only)
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