NeoControl

GUDID 00864618000322

Treatment Chair, NeoControl Pelvic Floor Therapy System

MAGIC RACE LLC

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 00864618000322
• NIH Device Record Key: 6552c5c2-0f59-4641-8b70-18c8df790119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoControl
• Version Model Number: N-0227-A
• Company DUNS: 080456235
• Company Name: MAGIC RACE 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: false
• 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: (498) 934-1040
• Email: info@kitalpha-med.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864618000322 [Primary]

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-01-08

On-Brand Devices [NeoControl]

• 00864618000322: Treatment Chair, NeoControl Pelvic Floor Therapy System
• 00864618000315: Control Unit, 110 volt, NeoControl Pelvic Floor Therapy System
• 00864618000308: Control Unit, 220 volt, NeoControl Pelvic Floor Therapy System