FDA.reportPublic FDA data

Three degrees

Primary DI
06976378040020
Brand
Three degrees
Company
Dong Guan Ou Kang Electronics CO.,LTD
Model
Circular
Device 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
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181234000Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd.2018-08-07GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976378040020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976378040020069763780400206976378040020

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554408363
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976378040082Three degrees 5*5 snap50*50mm*42026-05-08
06976378040075Three degrees Square50*50mm*3+Rectangle50*100mm*350*50mm*3+50*100mm*32026-04-13
06976378040068Three degrees Hand*3+Square*1+Ellipse*146*75mm*3+50*11mm*1+30*43mm*12026-02-02
06976378040006Three degreesRectangular2023-08-08
06976378040013Three degreesSquare2023-08-08
06976378040037Three degreesOval2023-08-08
06976378040044Three degreesHand shape2023-08-08

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Primary DI, Brand, Company table
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08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
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00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
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06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00850080988664AUVONUAN HEALTHCARE LIMITEDGXY2026-09-08
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04