Mothermed

GUDID 00818218024080

To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.

Famidoc Technology Co.,Ltd.

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• Primary Device ID: 00818218024080
• NIH Device Record Key: c3a8f455-8f18-4d85-97df-9174a266dbf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothermed
• Version Model Number: ES408
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818218024080 [Primary]

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: 2016-12-05

On-Brand Devices [Mothermed]

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• 00818218029009: Self-adhesive Electrode
• 00818218027029: Metal Comb
• 00818218027012: Electronic Lice Comb
• 00818218024080: To be used for temporary relief of pain associated with sore and aching muscles due to strain fr
• 00818218024073: Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdo
• 10818218024056: The product is suitable to be used for temporary relief of pain associated with sore and aching
• 00818218021225: This thermometer is intended for non-contact to measurement of forehead temperature at home or h
• 10818218021024: This product is suitable for measuring temperature of the human ear.
• 00818218020242: This clinical digital thermometer is intended for human body temperature, including oral,underar
• 00818218020112: This thermometer is intended for non-contact to measurement of forehead temperature at home or h