miha bodytec

GUDID 04260646650021

The “i-body connect wireless” is an extension for the control units “miha bodytec II” and “miha bodytec m.ove”. It serves as an external stimulation unit with a wireless connection to the control unit. i-body connect wireless makes it possible to train without a connection cable between the athlete and the control unit.

miha bodytec GmbH

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• Primary Device ID: 04260646650021
• NIH Device Record Key: fc4a4f88-5658-4eff-955a-bc47a17e49b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miha bodytec
• Version Model Number: i-body connect wireless
• Company DUNS: 551434728
• Company Name: miha bodytec GmbH
• 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	04260646650021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221498

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [miha bodytec]

• 04260646650007: miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regardi
• 04260646650021: The “i-body connect wireless” is an extension for the control units “miha bodytec II” an
• 04260646650014: miha bodytec m.ove is a device which performs electronic muscle stimulation based on EMS technol