Bodi-Tek

GUDID 06973209160087

Wireless Electronic Pulse Stimulator for Feet

Shenzhen Leading Perfectin Technology Co.,Ltd

Transcutaneous electrical stimulation electrode

• Primary Device ID: 06973209160087
• NIH Device Record Key: 0882a36f-c848-40de-b384-16e413200492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bodi-Tek
• Version Model Number: S3
• Company DUNS: 554459050
• Company Name: Shenzhen Leading Perfectin 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973209160087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183674

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: 2020-08-03
• Device Publish Date: 2020-07-24

Devices Manufactured by Shenzhen Leading Perfectin Technology Co.,Ltd

• 06973209160025 - VONMIE: 2021-02-19 TENS and PMS Arms and Legs Pad
• 06973209160032 - VONMIE: 2021-02-19 TENS and PMS Abdomen Pad
• 06973209160049 - VONMIE: 2021-02-19 TENS and PMS Feet Pad
• 06973209160056 - VONMIE: 2021-02-19 TENS and PMS Hips Pad
• 06973209160087 - Bodi-Tek: 2020-08-03Wireless Electronic Pulse Stimulator for Feet
• 06973209160087 - Bodi-Tek: 2020-08-03 Wireless Electronic Pulse Stimulator for Feet