Brace Direct

GUDID 00613527834173

BraceDirect’s IcedHeat Therapy Unit offers versatile cold and hot therapy solutions, designed for swift recovery from injuries, surgeries, or chronic conditions. With a whisper-quiet operation, this intuitive device ensures targeted relief for various body parts including the knee, hip, shoulder, and more.

BRACE ALIGN LLC

Circulating-fluid localized thermal therapy system

• Primary Device ID: 00613527834173
• NIH Device Record Key: 30739de9-c974-4cb3-8490-7155e78380d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brace Direct
• Version Model Number: CTY408
• Company DUNS: 108094498
• Company Name: BRACE ALIGN LLC
• 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: false
• Expiration Date: true
• 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	00613527834173 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

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: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [Brace Direct]

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• 00686162751389: Experience targeted relief from joint pain, post-workout fatigue, and post-surgery inflammation
• 00613527834173: BraceDirect’s IcedHeat Therapy Unit offers versatile cold and hot therapy solutions, designed