StimWear

GUDID B1900700

Conductive duo-sock, dual polarity, 1/package

Tensproducts, LLC

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B1900700
• NIH Device Record Key: 435de29e-56d1-42d2-be26-604fb440db18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimWear
• Version Model Number: PLB054-3020
• Company DUNS: 104307787
• Company Name: Tensproducts, LLC
• 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: true
• 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
HIBCC	B1900700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-23
• Device Publish Date: 2021-09-15

Devices Manufactured by Tensproducts, LLC

• B1900681 - StemWear: 2021-09-23 Conductive pad, 2in. x 3in., 2/package
• B1900691 - StemWear: 2021-09-23 Conductive pan, 3in. x5in., 2/package
• B1900700 - StimWear: 2021-09-23Conductive duo-sock, dual polarity, 1/package
• B1900700 - StimWear: 2021-09-23 Conductive duo-sock, dual polarity, 1/package
• B1900710 - StemWear: 2021-09-23 Conductive duo-elbow, duel polarity, 1/package
• B1900720 - StemWear: 2021-09-23 Conductive duo-knee, dual polarity, 1/package
• B1900730 - StemWear: 2021-09-23 Conductive duo-glove, dual polarity, 1/package