Omnistim 500 Pro

GUDID 00858703006016

The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency Alternating Currents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Its two separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuous or modulated modes. Two isolated output circuits with independent intensity controls are provided. The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF ramps provides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervated muscle. The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasing circulation, pain control and muscle re-ed can be set up in this mode.

ACCELERATED CARE PLUS CORP

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 00858703006016
• NIH Device Record Key: 7b9178b5-0a1a-4536-84c2-434333ff7447
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnistim 500 Pro
• Version Model Number: 100500C
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• 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

Customer Support Contacts

• Phone: 800-350-1100
• Email: customersupport@acplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006016 [Primary]
GS1	10858703006013 [Package]; Package: ship carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874076

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-08-16

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