AUVON

GUDID 06971292002307

The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

Shenzhen Yuwen E-Commerce Co., Ltd.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06971292002307
• NIH Device Record Key: b4694fe9-94af-4d85-912d-dd5a77dcb756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUVON
• Version Model Number: EB1M20021
• Company DUNS: 544559614
• Company Name: Shenzhen Yuwen E-Commerce Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971292002307 [Primary]
GS1	16971292002304 [Package]; Package: [110 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160138

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-13
• Device Publish Date: 2022-01-05

On-Brand Devices [AUVON]

• 16971292006258: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005513: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005506: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005251: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005237: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292005213: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005100: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292005087: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004417: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004028: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 26971292002929: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292001239: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292001215: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001154: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292001123: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001093: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292001041: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 69712920010450: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292000419: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 06971292004431: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 06971292001188: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292001178: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292002021: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292000324: To be used for the relief of pain associated with sore or aching muscles of the lower back, arms
• 16971292001246: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292002083: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001277: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001291: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the det
• 16971292002106: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292000478: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 16971292000430: TENS: To be used for temporary relief of pain associated with sore and aching muscles in the sh
• 16971292001376: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001352: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001338: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001314: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292000485: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001390: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292002113: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002120: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292000492: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292001413: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292001406: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 16971292000508: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002182: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002175: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002168: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 06971292002154: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee
• 16971292001420: The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnost
• 06971292002215: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface betwee
• 16971292002205: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface betwee