iSelfCare

GUDID 10817856020819

HEALTHMATE INTERNATIONAL,LLC

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 10817856020819
• NIH Device Record Key: 3135ed02-ecbd-45ab-bec6-8562cb9e83b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSelfCare
• Version Model Number: T40AB2 Black
• Company DUNS: 014593382
• Company Name: HEALTHMATE INTERNATIONAL,LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817856020812 [Primary]
GS1	10817856020819 [Package]; Contains: 00817856020812; Package: [36 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-08-06

On-Brand Devices [iSelfCare]

• 10817856020819: T40AB2 Black
• 10817856020802: T40AB1 Black
• 10817856020796: PRO24ABQ BLACK
• 10817856020789: PRO24AB2 BLACK
• 10817856020772: PRO24AB BLACK
• 10817856020765: NK24AB Black
• 10817856020758: HM24AB BLACK
• 20817856020748: BM24AB BLACK