XBody

GUDID 05999860571001

The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

XBODY HUNGARY Kft.

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• Primary Device ID: 05999860571001
• NIH Device Record Key: 1275a0ee-d74b-41a0-94dd-6a5d300aa948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XBody
• Version Model Number: Newave USA
• Company DUNS: 366728377
• Company Name: XBODY HUNGARY Kft.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999860571001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190038

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-07-31

On-Brand Devices [XBody]

• 05999860571001: The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. Th
• 05999860571070: The XBody Pro USA is a machine with electronic muscle stimulation based on EMS technology. The d
• 05999860571063: The XBody Go USA is a machine with electronic muscle stimulation based on EMS technology. The de