Mothermed

GUDID 10818218024056

The product is suitable 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.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10818218024056
• NIH Device Record Key: 3d599f28-4d5f-4afe-b408-32313389ee55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mothermed
• Version Model Number: ES405
• 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	00818218024059 [Primary]
GS1	10818218024056 [Package]; Contains: 00818218024059; Package: BOX [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-11-25

On-Brand Devices [Mothermed]

• 10818218029037: Self-adhesive Electrode
• 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