Omnistim FX2 Pro Sport

GUDID 00858703006030

The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a high intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretch receptors during voluntary activity.

ACCELERATED CARE PLUS CORP

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 00858703006030
• NIH Device Record Key: 10070f27-d911-4268-b25f-a780f0c4d769
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnistim FX2 Pro Sport
• Version Model Number: 100FX2D
• 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
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006030 [Primary]
GS1	10858703006037 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945509

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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