Transcutaneous Electrical Nerve Stimulator

GUDID 04897139961236

HONG KONG ETECH GROUPS LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04897139961236
• NIH Device Record Key: 68429d5a-9f6a-4829-aaec-619af3fbcedc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcutaneous Electrical Nerve Stimulator
• Version Model Number: 9029SCM, 9029
• Company DUNS: 687210485
• Company Name: HONG KONG ETECH GROUPS LIMITED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897139961236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240292

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2024-07-25
• Device Publish Date: 2024-07-17