Bodi-Tek

GUDID 06973209160087

Wireless Electronic Pulse Stimulator for Feet

Shenzhen Leading Perfectin Technology Co.,Ltd

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• 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

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• 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