HF54, Horizon

GUDID 00860001452532

HILL LABORATORIES CO.

Physical therapy ultrasound system

• Primary Device ID: 00860001452532
• NIH Device Record Key: a0071516-13e0-43ed-a76c-b0d30f1fe340
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HF54, Horizon
• Version Model Number: HF54, Horizon
• Company DUNS: 002326585
• Company Name: HILL LABORATORIES CO.
• 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: false
• Single Use: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001452532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062256

FDA Product Code

• IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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: 2020-02-12
• Device Publish Date: 2020-02-04

Devices Manufactured by HILL LABORATORIES CO.

• 00850058158143 - The SAVE Program: 2024-03-19
• 00850058158006 - HA90R: 2023-11-01
• 00850058158051 - HA90P: 2023-11-01
• 00850058158068 - HA90PH: 2023-11-01
• 00850058158075 - HA90PT: 2023-11-01
• 00850058158082 - HA90V: 2023-11-01
• 00850058158099 - HA90W: 2023-11-01
• 00850058158105 - HI-LO: 2023-11-01