HomeCare MF-HOMECARE

GUDID 00817076010839

MICRO CURRENT TECHNOLOGY, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00817076010839
• NIH Device Record Key: 833edd32-99ba-4996-a6e6-3f4c216efb66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HomeCare
• Version Model Number: S21
• Catalog Number: MF-HOMECARE
• Company DUNS: 121167779
• Company Name: MICRO CURRENT TECHNOLOGY, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00817076010839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033253

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: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-03-15

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• 00817076014219 - bt-sculpt: 2024-03-07
• 00817076010952 - bt-degree: 2020-05-25 IR Thermometer
• 00817076010877 - Bio- Ultimate Platinum: 2019-10-23
• 00817076010884 - bt-nano: 2019-10-23