TENS MAKER

GUDID 04719880810123

HIVOX BIOTEK INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04719880810123
• NIH Device Record Key: 3c9fd98b-94fd-4435-96df-66ae42f9f781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENS MAKER
• Version Model Number: WE-201
• Company DUNS: 658030473
• Company Name: HIVOX BIOTEK INC.
• 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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719880810123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141921

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2022-03-30
• Device Publish Date: 2022-03-22

On-Brand Devices [TENS MAKER]

• 04719880810000: WT-110
• 04719880810154: WT-110-2
• 04719880810147: WT-110-RF4
• 04719880810123: WE-201