Hyperice / NormaTec

GUDID 00810050288026

HYPERICE X2 KNEE

NORMATEC INDUSTRIES LP

Hot/cold therapy system

• Primary Device ID: 00810050288026
• NIH Device Record Key: 064ce28d-a431-4860-b6c5-d35ab2a8dd25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperice / NormaTec
• Version Model Number: HX20001
• Company DUNS: 111448069
• Company Name: NORMATEC INDUSTRIES LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050288026 [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: 2025-08-04
• Device Publish Date: 2025-07-25

On-Brand Devices [Hyperice / NormaTec]

• 00810050288033: HYPERICE X2 SHOULDER
• 00810050288026: HYPERICE X2 KNEE