Identity
- Trade Name
- ATLAS Stim Headbox Software FDA UDI
- Generic Name
- Somatosensory electrical stimulation system FDA UDI
- Device Name
- Control software for the ATLAS Stim Headbox. FDA UDI
- Model / Reference
- 1.5.1 FDA UDI
- Description
- Control software for the ATLAS Stim Headbox. FDA UDI
Identifiers
- Catalog Number
- 36-0301-0006 FDA UDI
- Primary DI / UDI-DI
- 00850011306703 FDA UDI
- 510(k) Number
- K250094 FDA UDI
- FDA Product Code
- GYC FDA UDI
- GMDN Term
- Somatosensory electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1310 FDA UDI
- Commercial Distribution
- Not 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
ATLAS Stim Headbox Software by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K250094 also covers:
- ATLAS Headbox Expansion Panel — NEURALYNX, INC.
- ATLAS Headbox Interface Cable - High Density — NEURALYNX, INC.
- ATLAS Headbox Interface Cable - NK — NEURALYNX, INC.
- ATLAS Headbox Interface Cable - Touchproof — NEURALYNX, INC.
- ATLAS Stim Headbox - High Density — NEURALYNX, INC.
- ATLAS Stim Headbox - NK — NEURALYNX, INC.
- ATLAS Stim Headbox - Touchproof — NEURALYNX, INC.
- Fiber Optic Connector 2m — NEURALYNX, INC.
- Fiber Optic Connector 7m — NEURALYNX, 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
- Neuralynx, Inc.
Sources (1)
- FDA UDI 57568104-9f7d-4de8-ba14-79017085b5fe 36 fields · synced May 31, 2026