CS-Pro MED

GUDID 00860014430503

CURATIVE SOUND, LLC

Multidisciplinary extracorporeal shock wave therapy system, hand-held

• Primary Device ID: 00860014430503
• NIH Device Record Key: f0d425d4-5220-4256-9b0f-775207d8c69e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS-Pro MED
• Version Model Number: CS-Pro MED
• Company DUNS: 108756583
• Company Name: CURATIVE SOUND, LLC
• 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: 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	00860014430503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250779

FDA Product Code

• PZL: Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

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: 2026-01-12
• Device Publish Date: 2026-01-02