Identity
- Trade Name
- NeuroStar Headrest FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- The NeuroStar Headrest can be adjusted to the patient's comfort. FDA UDI
- Model / Reference
- 81-72026-000 FDA UDI
- Description
- The NeuroStar Headrest can be adjusted to the patient's comfort. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005944348 FDA UDI
- 510(k) Number
- K233621 FDA UDI
- FDA Product Code
- OBP FDA UDIQCI FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5805 FDA UDI882.5802 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Magnetic neural stimulation system
NeuroStar Headrest by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233621 also covers:
- NeuroSITE — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar Advanced Therapy System — Neuronetics Inc.
- NeuroStar System Software — Neuronetics Inc.
- TrakStar Patient Data Management System Software — Neuronetics Inc.
- TrakStar Patient Data Management System Software — Neuronetics Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neuronetics Inc.
Sources (1)
- FDA UDI 34f5a2a2-bb36-48d2-bb7d-ee166cf6444c 35 fields · synced May 30, 2026