Hilthera 4.0 N/A

GUDID 08809326582113

REV-MED Inc.

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 08809326582113
• NIH Device Record Key: c9681f4b-dfa9-4dbc-a920-81367fb6c584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hilthera 4.0
• Version Model Number: RM-211
• Catalog Number: N/A
• Company DUNS: 557800328
• Company Name: REV-MED Inc.
• 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: true
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809326582113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141861

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: 2025-12-11
• Device Publish Date: 2025-12-03