Famidoc

GUDID 00854314007510

ABDOMINAL FITNESS BELT

FAMIDOC USA, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00854314007510
• NIH Device Record Key: dd960a17-fedd-498f-9b2b-8496cab1194a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Famidoc
• Version Model Number: FDES107
• Company DUNS: 080370811
• Company Name: FAMIDOC USA, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00854314007510 [Primary]
GS1	10854314007517 [Package]; Package: [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-12-29

On-Brand Devices [Famidoc]

• 00854314007527: Multi-function TENS&EMS Dual pad device
• 00854314007510: ABDOMINAL FITNESS BELT
• 00854314007503: Pain Relief Plaster
• 00854314007350: DIGITAL CLINICAL THERMOMETER
• 00854314007343: DIGITAL CLINICAL THERMOMETER
• 00854314007336: DIGITAL CLINICAL THERMOMETER
• 00854314007329: DIGITAL CLINICAL THERMOMETER
• 00854314007312: DIGITAL CLINICAL THERMOMETER
• 00854314007305: DIGITAL CLINICAL THERMOMETER
• 00854314007121: Non-Contact Infrared Thermometer
• 00854314007114: Non-contact Infrared thermometer
• 00854314007107: Infrared Ear Thermometer
• 00854314007084: FDCO-V11
• 00854314007015: Metal Comb
• 00854314007008: Elecronic Comb