miha bodytec

GUDID 04260646650007

miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for healthy muscles and clients, not be used for rehabilitation purposes.

miha bodytec GmbH

Physical therapy transcutaneous electrical stimulation system, line-powered

• Primary Device ID: 04260646650007
• NIH Device Record Key: 64eab4a7-d006-44dd-9d7d-aad86476bd61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miha bodytec
• Version Model Number: miha bodytec II
• 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	04260646650007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182519

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: 2019-07-04
• Device Publish Date: 2019-06-26

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