Identity
- Trade Name
- Alpha-Stim Earclip Electrode (AID) FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Alpha-Stim Earclip Electrode (AID) RoHS compliant FDA UDI
- Model / Reference
- Earclip Electrode (AID) [RoHS] FDA UDI
- Description
- Alpha-Stim Earclip Electrode (AID) RoHS compliant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857869005178 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 (AID) by Electromedical Products International, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Alpha-Stim AID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Electromedical Products International, Inc.
Sources (1)
- FDA UDI 5b597aee-c84c-4da5-9f40-a0d3389dccf5 34 fields · synced May 30, 2026