Identity
- Trade Name
- Three degrees FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Φ32, Φ35, Φ40, Φ45, Φ50, Φ52, Φ55, Φ60, Φ64, Φ65, Φ70, Φ75, Φ80, Φ90, Φ100, Φ110, Φ115, Φ120, Φ130, Φ135, Φ150, Φ160 FDA UDI
- Model / Reference
- Circular FDA UDI
- Description
- Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Φ32, Φ35, Φ40, Φ45, Φ50, Φ52, Φ55, Φ60, Φ64, Φ65, Φ70, Φ75, Φ80, Φ90, Φ100, Φ110, Φ115, Φ120, Φ130, Φ135, Φ150, Φ160 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976378040020 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 e4def046-8c3b-4440-8e40-39227057f54d 34 fields · synced Jun 1, 2026