Identity
- Trade Name
- Alpha-Stim Earclip Electrode (M) FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Alpha-Stim Earclip Electrode (M) RoHS compliant FDA UDI
- Model / Reference
- Earclip Electrode (M) [RoHS] FDA UDI
- Description
- Alpha-Stim Earclip Electrode (M) RoHS compliant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857869005161 FDA UDI
- FDA Product Code
- JXK FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 882.5800 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Alpha-Stim Earclip Electrode (M) by Electromedical Products International, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Electromedical Products International, Inc.
Sources (1)
- FDA UDI ebf63866-9263-462e-aa49-4d08034fed13 34 fields · synced May 30, 2026