AcuZone

GUDID 16959006303329

AcuZone-44-2x2 pigtail electrodes, for TENS EMS

CATHAY MANUFACTURING CORP.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 16959006303329
• NIH Device Record Key: 39c49856-9ce7-4032-ab62-70c08a7a4290
• Commercial Distribution Discontinuation: 2025-11-12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuZone
• Version Model Number: AcuZone-44-2x2 pigtail electrodes
• Company DUNS: 421287342
• Company Name: CATHAY MANUFACTURING CORP.
• Device Count: 11
• DM Exempt: true
• 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: false
• 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	06959006303322 [Primary]
GS1	16959006303329 [Package]; Contains: 06959006303322; Package: PE POUCH [50 Units]; Discontinued: 2025-11-11; In Commercial Distribution
GS1	26959006303326 [Unit of Use]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-19
• Device Publish Date: 2020-11-13

On-Brand Devices [AcuZone]

• 16959006303336: AcuZone-40-2x2SNAP electrodes, FOR use with TENS, EMS
• 16959006303329: AcuZone-44-2x2 pigtail electrodes, for TENS EMS
• 16959006303312: AcuZone-40-2x4pigtail electrodes, Adhesive electrodes for TENS EMS