Identity
- Trade Name
- Electrical Stimulation Box FDA UDI
- Generic Name
- Somatosensory electrical stimulation system FDA UDI
- Model / Reference
- M014910 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020297 FDA UDI
- 510(k) Number
- K070608 FDA UDI
- FDA Product Code
- GWF FDA UDI
- GMDN Term
- Somatosensory electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 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: Somatosensory electrical stimulation system
Electrical Stimulation Box by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Somatosensory electrical stimulation system.
- ATLAS Stim Headbox - High Density — NEURALYNX, INC. · Class II
- Micromed — Micromed, Inc. · Class II
- ATLAS Headbox Expansion Panel — NEURALYNX, INC. · Class II
- ATLAS Stim Headbox - NK — NEURALYNX, INC. · Class II
- ATLAS Stim Headbox - Touchproof — NEURALYNX, INC. · Class II
- USB to Electrical Stimulation Box Cable — Intelligent Hearing Systems Corp. · Class II
- Electrical Stimulator Probe — Intelligent Hearing Systems Corp. · Class II
Cleared under the same submission
K070608 also covers:
- Electrical Stimulator Probe — Intelligent Hearing Systems Corp.
- SmartEP Software — Intelligent Hearing Systems Corp.
- USB to Electrical Stimulation Box Cable — Intelligent Hearing Systems Corp.
- Universal Smart Box — Intelligent Hearing Systems Corp.
- Visual Stimulation Box — Intelligent Hearing Systems Corp.
- eABR Cable — Intelligent Hearing Systems Corp.
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
- Intelligent Hearing Systems Corp.
Sources (1)
- FDA UDI 10be2bb1-f822-41c6-9d0b-937fc9e520e3 33 fields · synced Jun 8, 2026