CPS-2000

GUDID 00860012519507

Interferential Current Therapy Device

SURGITECH, INC.

Interferential electrical stimulation system

• Primary Device ID: 00860012519507
• NIH Device Record Key: 7e8aa17c-dd7b-4b6b-b81f-12f41174e561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS-2000
• Version Model Number: CPS-2000
• Company DUNS: 138847715
• Company Name: SURGITECH, 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: 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	00860012519507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033358

FDA Product Code

• LIH: Interferential Current Therapy

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: 2025-04-08
• Device Publish Date: 2025-03-31