CARELight 602019

GUDID 00858935006464

Foot & Ankle Red/IR CAREPad - Infrared Phototherapy Device

HEALTHLIGHT LLC

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00858935006464
• NIH Device Record Key: 2613d19b-639c-4707-9019-cdeda0139d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARELight
• Version Model Number: CL-PB
• Catalog Number: 602019
• Company DUNS: 080183509
• Company Name: HEALTHLIGHT 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858935006464 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2020-01-07
• Device Publish Date: 2019-12-30

On-Brand Devices [CARELight]

• 00858935006471: Face Mask CAREPad - Phototherapy Device
• 00858935006464: Foot & Ankle Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006457: 64-LED Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006440: Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters
• 00858935006433: Six Port CAREController - Phototherapy Control Device for up to 6 separate phototherapy emitters
• 00858935006426: Foot & Calf Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006419: 264-LED Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006402: 180-LED Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006396: 132-LED Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006389: 90-LED Red/IR CAREPad - Infrared Phototherapy Device
• 00858935006600: 261-LED Red/IR T-shape CAREPad - Infrared Phototherapy Device
• 00858935006518: 132-LED Blue/IR CAREPad - Infrared Phototherapy Device
• 00858935006501: Three Port CAREController - Phototherapy Control Device for up to 3 separate phototherapy emitte
• 00858935006495: 180-LED Tricolor Blue/IR/Red CAREPad - Infrared Phototherapy Device
• 00858935006488: 264-LED Blue/IR CAREPad - Infrared Phototherapy Device
• 00858935006648: CAREPad 64 Red-IR and controller LED Infrared Phototherapy System
• 00858935006631: CAREPad 180R Red-IR and controller Infrared LED Phototherapy System
• 00858935006662: 204-LED Red/IR Knee CAREPad - Infrared Phototherapy Device
• 00858935006686: Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters