Identity
- Trade Name
- Three degrees FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Oval shape TENS/EMS Electrode Pads includes specification of 15*60, 30*43, 30*50, 40*60, 42*67, 46*75, 50*70, 50*90, 60*90, 70*100, 70*110, 70*140, 80*100, 80*120, 80*140, 90*130, 100*198, 202*245. FDA UDI
- Model / Reference
- Oval FDA UDI
- Description
- Oval shape TENS/EMS Electrode Pads includes specification of 15*60, 30*43, 30*50, 40*60, 42*67, 46*75, 50*70, 50*90, 60*90, 70*100, 70*110, 70*140, 80*100, 80*120, 80*140, 90*130, 100*198, 202*245. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976378040037 FDA UDI
- 510(k) Number
- K181234 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Three degrees by Dong Guan Ou Kang Electronics CO., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Dong Guan Ou Kang Electronics CO., LTD
Sources (1)
- FDA UDI d7bbf006-e258-4c56-90db-2e9a29a0bebf 34 fields · synced Jun 8, 2026