Welby

GUDID 06926408710317

3 IN 1: TENS, EMS AND MASSAGE DEVICE

Shenzhen Dongdixin Technology Co.,Ltd.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06926408710317
• NIH Device Record Key: de5c3b0c-e9d3-422a-97a0-4393d4177195
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welby
• Version Model Number: TEN603
• Company DUNS: 545301488
• Company Name: Shenzhen Dongdixin Technology 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	06926408710317 [Primary]
GS1	16926408710314 [Package]; Package: [4 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-06-04

Devices Manufactured by Shenzhen Dongdixin Technology Co.,Ltd.

• 06926408700455 - CARETALK: 2020-04-15 The device is Non-Contact thermometer, which is intended to measure human body temperature
• 16926408700209 - CARETALK: 2020-03-27 The device is Non-Contact thermometer, which is intended to measure human body temperature
• 06926408710317 - Welby: 2019-10-233 IN 1: TENS, EMS AND MASSAGE DEVICE
• 06926408710317 - Welby: 2019-10-23 3 IN 1: TENS, EMS AND MASSAGE DEVICE
• 06926408700165 - Little Journey: 2018-08-31 The device is Non-Contact thermometer, which is intended to measure human body temperature
• 20075020053293 - Philips Avent ear thermometer: 2018-08-20
• 06926408700011 - Little Journey: 2018-07-06 The device is an Ear and forehead thermometer, which is intended to measure human body temperature.
• 00075020054043 - Philips ear thermometer: 2018-07-06