Three degrees

GUDID 06976378040044

Hand shape TENS/EMS Electrode Pads includes specification of 25*50, 46*75, 50*78, 55*80, 64*78, 72*90.

Dong Guan Ou Kang Electronics CO.,LTD

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06976378040044
• NIH Device Record Key: bb74a89c-bf57-4c59-bd55-9ee5b1ffe922
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Three degrees
• Version Model Number: Hand shape
• Company DUNS: 554408363
• Company Name: Dong Guan Ou Kang Electronics CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976378040044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181234

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-16
• Device Publish Date: 2023-08-08

On-Brand Devices [Three degrees]

• 06976378040044: Hand shape TENS/EMS Electrode Pads includes specification of 25*50, 46*75, 50*78, 55*80, 64*78,
• 06976378040037: Oval shape TENS/EMS Electrode Pads includes specification of 15*60, 30*43, 30*50, 40*60, 42*67,
• 06976378040020: Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Î
• 06976378040013: Square shape TENS/EMS Electrode Pads includes specification of 20*20, 30*30, 40*40, 50*50, 6
• 06976378040006: Rectangular shape TENS/EMS Electrode Pads includes specification of 10*100, 15*40, 17*70, 20*40,