CareWear ®

GUDID 44719872330491

The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches s

ZMI ELECTRONICS LTD.

Musculoskeletal/physical therapy laser, home-use

• Primary Device ID: 44719872330491
• NIH Device Record Key: 665308bb-98e6-4480-a9c5-c50ce9f021c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareWear ®
• Version Model Number: CWC-1
• Company DUNS: 657406062
• Company Name: ZMI ELECTRONICS LTD.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net
• Phone: 775-250-4857
• Email: twei@carewear.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872330479 [Primary]
GS1	04719872330578 [Package]; Contains: 04719872330479; Package: Carry case & sleeve [1 Units]; In Commercial Distribution
GS1	04719872330585 [Package]; Contains: 04719872330479; Package: carry case & sleeve [4 Units]; In Commercial Distribution
GS1	14719872330483 [Package]; Contains: 04719872330479; Package: carry case [1 Units]; In Commercial Distribution
GS1	44719872330491 [Package]; Contains: 04719872330479; Package: carry case [4 Units]; In Commercial Distribution

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2019-01-08
• Device Publish Date: 2018-06-26

Devices Manufactured by ZMI ELECTRONICS LTD.

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• 04719872333302 - Levina: 2024-02-27 Self-adhesive electrode, butterfly + round type (Pink)
• 04719872333319 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type (Pink)
• 04719872333357 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type: D68x141mm (Blue)
• 04719872333371 - Levina: 2024-02-27 Self-adhesive electrode, butterfly type: D53x111mm (Blue)
• 04719872333395 - Levina: 2024-02-27 Self-adhesive electrode, round type (Pink)