Echo Ultrasound Device (USA) 0V52XX1002JK01

GUDID 00850033615340

Echo Ultrasound Device (USA), Single

THERMOTEK, INC.

Physical therapy ultrasound system

• Primary Device ID: 00850033615340
• NIH Device Record Key: 1fb76da7-740e-4c43-834e-be90cc8d888d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo Ultrasound Device (USA)
• Version Model Number: 0V52XX1002JK01
• Catalog Number: 0V52XX1002JK01
• Company DUNS: 847899911
• Company Name: THERMOTEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	00850033615340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240788

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: 2026-03-03
• Device Publish Date: 2026-02-23

On-Brand Devices [Echo Ultrasound Device (USA)]

• 00850033615340: Echo Ultrasound Device (USA), Single
• 00850033615289: Echo Ultrasound Device (USA), Carton