Famidoc

GUDID 06970389634018

The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，Post traumatic pain，post surgical pain，Relaxation of muscle spasm， Increase blood flow circulation，Prevention or retardation of disuse atrophy， Muscle re-education， Maintaining or increasing range of motion，Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Famidoc Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970389634018
• NIH Device Record Key: b7b6b133-2c79-4e0d-81e4-f4a29ebb5657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Famidoc
• Version Model Number: FDES101
• Company DUNS: 421343701
• Company Name: Famidoc 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970389634018 [Primary]
GS1	16970389634015 [Package]; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113010

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2016-10-17

On-Brand Devices [Famidoc]

• 10818218022120: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022045: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022038: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218022014: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218021109: This thermometer is intended with non-contact to measurement forehead temperature at home or hos
• 10818218020027: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 10818218020010: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 06970389634018: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 06970389631222: FDIR-V22
• 06970389631161: FDIR-V16
• 06970389631154: FDIR-V15
• 06970389631109: FDIR-V10
• 06970389631093: FDIR-V9
• 06970389631079: FDIR-V7
• 06970389631062: FDIR-V6
• 06970389631055: FDIR-V5
• 06970389631048: FDIR-V4
• 06970389631031: FDIR-V3
• 06970389631024: FDIR-V2
• 06970389631017: FDIR-V1
• 06970389630102: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 06970389630096: The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，P
• 00854314007268: FDES107
• 00854314007251: FDIR-V4
• 00854314007176: FDIR-V4
• 00854314007169: FDES116
• 00854314007138: FDIR-V16
• 00854314007060: FDES108
• 00854314007022: FDES108
• 06970389634162: FDES116
• 06970389634087: FDES108
• 06970389631277: FDIR-V16
• 06970389631215: FDIR-V4
• 00818218024783: FDES108
• 00818218024776: FDES107
• 00818218021041: FDIR-V4
• 00818218023014: FDBP-A4
• 06970389632250: FDIR-V22
• 06970389632342: FDIR-V24
• 06970389632328: FDIR-V13
• 06970389632281: FDIR-V12
• 06970389632168: FDTH-V0-16
• 06970389632151: FDTH-V0-15
• 06970389632144: FDTH-V0-14
• 06970389632137: FDTH-V0-13
• 06970389632113: FDTH-V0-11
• 06970389632090: FDTH-V0-9
• 06970389632083: FDTH-V0-8
• 06970389632076: FDTH-V0-7
• 06970389632069: FDTH-V0-6