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Three degrees

FDA UDI

Class II (US FDA UDI)

by Dong Guan Ou Kang Electronics CO., LTD

Identity

Trade Name
Three degrees FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40, 20*80, 20*100, 25*35, 30*50, 30*60, 30*70, 30*90, 32*95, 35*45, 35*50, 35*70, 35*82, 40*53, 40*60, 40*70, 40*90, 40*100, 45*60, 45*70, 45*90, 45*95, 46*73, 50*55, 50*60, 50*70, 50*80, 50*90, 50*100, 52*78, 53*210, 55*90, 50*96, 55*100, 60*70, 60*80, 60*90, 60*100, 62*96, 65*140, 68*88, 70*70, 70*100, 70*110, 70*130, 70*140, 73*160, 90*130, 95*100, 95*195, 96*162, 98*220, 100*150, 110*150, 115*180, 150*200. FDA UDI
Model / Reference
Rectangular FDA UDI
Description
Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40, 20*80, 20*100, 25*35, 30*50, 30*60, 30*70, 30*90, 32*95, 35*45, 35*50, 35*70, 35*82, 40*53, 40*60, 40*70, 40*90, 40*100, 45*60, 45*70, 45*90, 45*95, 46*73, 50*55, 50*60, 50*70, 50*80, 50*90, 50*100, 52*78, 53*210, 55*90, 50*96, 55*100, 60*70, 60*80, 60*90, 60*100, 62*96, 65*140, 68*88, 70*70, 70*100, 70*110, 70*130, 70*140, 73*160, 90*130, 95*100, 95*195, 96*162, 98*220, 100*150, 110*150, 115*180, 150*200. FDA UDI

Identifiers

Primary DI / UDI-DI
06976378040006 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

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, single-use.

Cleared under the same submission

K181234 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dong Guan Ou Kang Electronics CO., LTD

Sources (1)

  • FDA UDI 133247bf-e895-4586-8d21-46c3de145791 34 fields · synced Jun 1, 2026